Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial
Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, R...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Sarris, Jerome [verfasserIn] Byrne, Gerard J [verfasserIn] Stough, Con [verfasserIn] Bousman, Chad [verfasserIn] Mischoulon, David [verfasserIn] Murphy, Jenifer [verfasserIn] Macdonald, Patricia [verfasserIn] Adams, Laura [verfasserIn] Nazareth, Sonia [verfasserIn] Oliver, Georgina [verfasserIn] Cribb, Lachlan [verfasserIn] Savage, Karen [verfasserIn] Menon, Ranjit [verfasserIn] Chamoli, Suneel [verfasserIn] Berk, Michael [verfasserIn] Ng, Chee H [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2018 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Journal of affective disorders - Amsterdam [u.a.] : Elsevier Science, 1979, 245, Seite 1007-1015 |
|---|---|
| Übergeordnetes Werk: |
volume:245 ; pages:1007-1015 |
| DOI / URN: |
10.1016/j.jad.2018.11.092 |
|---|
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| 245 | 1 | 0 | |a Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial |
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| 520 | |a Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group.Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable.Interpretation: The adoption of a nutraceutical ‘shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. | ||
| 650 | 4 | |a Antidepressant | |
| 650 | 4 | |a Nutraceutical | |
| 650 | 4 | |a Nutrient | |
| 650 | 4 | |a Depression | |
| 650 | 4 | |a Clinical trial | |
| 650 | 4 | |a Pharmacogenomics | |
| 700 | 1 | |a Byrne, Gerard J |e verfasserin |0 (orcid)0000-0001-8259-3812 |4 aut | |
| 700 | 1 | |a Stough, Con |e verfasserin |4 aut | |
| 700 | 1 | |a Bousman, Chad |e verfasserin |4 aut | |
| 700 | 1 | |a Mischoulon, David |e verfasserin |4 aut | |
| 700 | 1 | |a Murphy, Jenifer |e verfasserin |4 aut | |
| 700 | 1 | |a Macdonald, Patricia |e verfasserin |4 aut | |
| 700 | 1 | |a Adams, Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Nazareth, Sonia |e verfasserin |4 aut | |
| 700 | 1 | |a Oliver, Georgina |e verfasserin |4 aut | |
| 700 | 1 | |a Cribb, Lachlan |e verfasserin |4 aut | |
| 700 | 1 | |a Savage, Karen |e verfasserin |4 aut | |
| 700 | 1 | |a Menon, Ranjit |e verfasserin |4 aut | |
| 700 | 1 | |a Chamoli, Suneel |e verfasserin |0 (orcid)0000-0002-1495-8282 |4 aut | |
| 700 | 1 | |a Berk, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Ng, Chee H |e verfasserin |0 (orcid)0000-0002-3811-2732 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of affective disorders |d Amsterdam [u.a.] : Elsevier Science, 1979 |g 245, Seite 1007-1015 |h Online-Ressource |w (DE-627)306659670 |w (DE-600)1500487-9 |w (DE-576)081986327 |x 1573-2517 |7 nnns |
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10.1016/j.jad.2018.11.092 doi (DE-627)ELV001509241 (ELSEVIER)S0165-0327(18)31411-3 DE-627 ger DE-627 rda eng 610 DE-600 44.91 bkl Sarris, Jerome verfasserin aut Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group.Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable.Interpretation: The adoption of a nutraceutical ‘shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. Antidepressant Nutraceutical Nutrient Depression Clinical trial Pharmacogenomics Byrne, Gerard J verfasserin (orcid)0000-0001-8259-3812 aut Stough, Con verfasserin aut Bousman, Chad verfasserin aut Mischoulon, David verfasserin aut Murphy, Jenifer verfasserin aut Macdonald, Patricia verfasserin aut Adams, Laura verfasserin aut Nazareth, Sonia verfasserin aut Oliver, Georgina verfasserin aut Cribb, Lachlan verfasserin aut Savage, Karen verfasserin aut Menon, Ranjit verfasserin aut Chamoli, Suneel verfasserin (orcid)0000-0002-1495-8282 aut Berk, Michael verfasserin aut Ng, Chee H verfasserin (orcid)0000-0002-3811-2732 aut Enthalten in Journal of affective disorders Amsterdam [u.a.] : Elsevier Science, 1979 245, Seite 1007-1015 Online-Ressource (DE-627)306659670 (DE-600)1500487-9 (DE-576)081986327 1573-2517 nnns volume:245 pages:1007-1015 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.91 Psychiatrie Psychopathologie AR 245 1007-1015 |
| spelling |
10.1016/j.jad.2018.11.092 doi (DE-627)ELV001509241 (ELSEVIER)S0165-0327(18)31411-3 DE-627 ger DE-627 rda eng 610 DE-600 44.91 bkl Sarris, Jerome verfasserin aut Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group.Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable.Interpretation: The adoption of a nutraceutical ‘shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. Antidepressant Nutraceutical Nutrient Depression Clinical trial Pharmacogenomics Byrne, Gerard J verfasserin (orcid)0000-0001-8259-3812 aut Stough, Con verfasserin aut Bousman, Chad verfasserin aut Mischoulon, David verfasserin aut Murphy, Jenifer verfasserin aut Macdonald, Patricia verfasserin aut Adams, Laura verfasserin aut Nazareth, Sonia verfasserin aut Oliver, Georgina verfasserin aut Cribb, Lachlan verfasserin aut Savage, Karen verfasserin aut Menon, Ranjit verfasserin aut Chamoli, Suneel verfasserin (orcid)0000-0002-1495-8282 aut Berk, Michael verfasserin aut Ng, Chee H verfasserin (orcid)0000-0002-3811-2732 aut Enthalten in Journal of affective disorders Amsterdam [u.a.] : Elsevier Science, 1979 245, Seite 1007-1015 Online-Ressource (DE-627)306659670 (DE-600)1500487-9 (DE-576)081986327 1573-2517 nnns volume:245 pages:1007-1015 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.91 Psychiatrie Psychopathologie AR 245 1007-1015 |
| allfields_unstemmed |
10.1016/j.jad.2018.11.092 doi (DE-627)ELV001509241 (ELSEVIER)S0165-0327(18)31411-3 DE-627 ger DE-627 rda eng 610 DE-600 44.91 bkl Sarris, Jerome verfasserin aut Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group.Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable.Interpretation: The adoption of a nutraceutical ‘shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. Antidepressant Nutraceutical Nutrient Depression Clinical trial Pharmacogenomics Byrne, Gerard J verfasserin (orcid)0000-0001-8259-3812 aut Stough, Con verfasserin aut Bousman, Chad verfasserin aut Mischoulon, David verfasserin aut Murphy, Jenifer verfasserin aut Macdonald, Patricia verfasserin aut Adams, Laura verfasserin aut Nazareth, Sonia verfasserin aut Oliver, Georgina verfasserin aut Cribb, Lachlan verfasserin aut Savage, Karen verfasserin aut Menon, Ranjit verfasserin aut Chamoli, Suneel verfasserin (orcid)0000-0002-1495-8282 aut Berk, Michael verfasserin aut Ng, Chee H verfasserin (orcid)0000-0002-3811-2732 aut Enthalten in Journal of affective disorders Amsterdam [u.a.] : Elsevier Science, 1979 245, Seite 1007-1015 Online-Ressource (DE-627)306659670 (DE-600)1500487-9 (DE-576)081986327 1573-2517 nnns volume:245 pages:1007-1015 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.91 Psychiatrie Psychopathologie AR 245 1007-1015 |
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10.1016/j.jad.2018.11.092 doi (DE-627)ELV001509241 (ELSEVIER)S0165-0327(18)31411-3 DE-627 ger DE-627 rda eng 610 DE-600 44.91 bkl Sarris, Jerome verfasserin aut Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group.Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable.Interpretation: The adoption of a nutraceutical ‘shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. Antidepressant Nutraceutical Nutrient Depression Clinical trial Pharmacogenomics Byrne, Gerard J verfasserin (orcid)0000-0001-8259-3812 aut Stough, Con verfasserin aut Bousman, Chad verfasserin aut Mischoulon, David verfasserin aut Murphy, Jenifer verfasserin aut Macdonald, Patricia verfasserin aut Adams, Laura verfasserin aut Nazareth, Sonia verfasserin aut Oliver, Georgina verfasserin aut Cribb, Lachlan verfasserin aut Savage, Karen verfasserin aut Menon, Ranjit verfasserin aut Chamoli, Suneel verfasserin (orcid)0000-0002-1495-8282 aut Berk, Michael verfasserin aut Ng, Chee H verfasserin (orcid)0000-0002-3811-2732 aut Enthalten in Journal of affective disorders Amsterdam [u.a.] : Elsevier Science, 1979 245, Seite 1007-1015 Online-Ressource (DE-627)306659670 (DE-600)1500487-9 (DE-576)081986327 1573-2517 nnns volume:245 pages:1007-1015 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.91 Psychiatrie Psychopathologie AR 245 1007-1015 |
| allfieldsSound |
10.1016/j.jad.2018.11.092 doi (DE-627)ELV001509241 (ELSEVIER)S0165-0327(18)31411-3 DE-627 ger DE-627 rda eng 610 DE-600 44.91 bkl Sarris, Jerome verfasserin aut Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group.Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable.Interpretation: The adoption of a nutraceutical ‘shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. Antidepressant Nutraceutical Nutrient Depression Clinical trial Pharmacogenomics Byrne, Gerard J verfasserin (orcid)0000-0001-8259-3812 aut Stough, Con verfasserin aut Bousman, Chad verfasserin aut Mischoulon, David verfasserin aut Murphy, Jenifer verfasserin aut Macdonald, Patricia verfasserin aut Adams, Laura verfasserin aut Nazareth, Sonia verfasserin aut Oliver, Georgina verfasserin aut Cribb, Lachlan verfasserin aut Savage, Karen verfasserin aut Menon, Ranjit verfasserin aut Chamoli, Suneel verfasserin (orcid)0000-0002-1495-8282 aut Berk, Michael verfasserin aut Ng, Chee H verfasserin (orcid)0000-0002-3811-2732 aut Enthalten in Journal of affective disorders Amsterdam [u.a.] : Elsevier Science, 1979 245, Seite 1007-1015 Online-Ressource (DE-627)306659670 (DE-600)1500487-9 (DE-576)081986327 1573-2517 nnns volume:245 pages:1007-1015 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.91 Psychiatrie Psychopathologie AR 245 1007-1015 |
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Sarris, Jerome @@aut@@ Byrne, Gerard J @@aut@@ Stough, Con @@aut@@ Bousman, Chad @@aut@@ Mischoulon, David @@aut@@ Murphy, Jenifer @@aut@@ Macdonald, Patricia @@aut@@ Adams, Laura @@aut@@ Nazareth, Sonia @@aut@@ Oliver, Georgina @@aut@@ Cribb, Lachlan @@aut@@ Savage, Karen @@aut@@ Menon, Ranjit @@aut@@ Chamoli, Suneel @@aut@@ Berk, Michael @@aut@@ Ng, Chee H @@aut@@ |
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Sarris, Jerome |
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Sarris, Jerome ddc 610 bkl 44.91 misc Antidepressant misc Nutraceutical misc Nutrient misc Depression misc Clinical trial misc Pharmacogenomics Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial |
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610 DE-600 44.91 bkl Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial Antidepressant Nutraceutical Nutrient Depression Clinical trial Pharmacogenomics |
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Sarris, Jerome Byrne, Gerard J Stough, Con Bousman, Chad Mischoulon, David Murphy, Jenifer Macdonald, Patricia Adams, Laura Nazareth, Sonia Oliver, Georgina Cribb, Lachlan Savage, Karen Menon, Ranjit Chamoli, Suneel Berk, Michael Ng, Chee H |
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nutraceuticals for major depressive disorder- more is not merrier: an 8-week double-blind, randomised, controlled trial |
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Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial |
| abstract |
Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group.Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable.Interpretation: The adoption of a nutraceutical ‘shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. |
| abstractGer |
Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group.Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable.Interpretation: The adoption of a nutraceutical ‘shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. |
| abstract_unstemmed |
Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect.Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group.Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable.Interpretation: The adoption of a nutraceutical ‘shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. |
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Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial |
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The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted.Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. 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