Evidence profile - pharmacological treatments: prophylaxis of severe mental illness

Forest plot identifierDescriptionStudy IdsQuality of included studiesConsistencyDirectnessOther factorsN treatment group/N controlEffect sizeAbsolute statistics (where appropriate)Likelihood of clinically important effectOverall quality
Prophylaxis of bipolar disorder
Divalproex + monitoring versus monitoring only (prophylaxis of bipolar disorder)
RMpproph 03.01Hypomania/mania episodeWisner2004A USASIGN: 2+ (−1)N/ARelevantSparse/imprecise data (−1)15/11RR = 0.73 (0.05, 10.49)7%9%InconclusiveLow
RMpproph 03.01Mixed state episodeWisner2004A USASIGN: 2+ (−1)N/ARelevantSparse/imprecise data (−1)15/11RR = 0.37 (0.04, 3.55)7%18%InconclusiveLow
RMpproph 03.01Depression episodeWisner2004A USASIGN: 2+ (−1)N/ARelevantSparse/imprecise data (−1)15/11RR = 1.17 (0.53, 2.62)53%45%InconclusiveLow
RMpproph 03.01Recurrence any episode (DSM-IV) (completer)Wisner2004A USASIGN: 2+ (−1)N/ARelevantSparse/imprecise data (−1)45/33RR = 0.92 (0.44, 1.91)22%24%InconclusiveLow
Mood stabilisers versus standard care (prophylaxis of bipolar disorder)
RMpproph 04.01"Relapse" in first 3 months postpartumCohen1995 USASIGN: 2− (−1)N/ARelevantSparse/imprecise data (−1)14/13RR = 0.12 (0.02, 0.81)7%62%Likely (favouring mood stabilisers)Low
Prophylaxis of major depression
Nortriptyline versus placebo
RMpprev 05.01Leaving study early for any reason except recurrenceWisner2001 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)29/27RR = 0.74 (0.22, 2.49)14%19%InconclusiveLow
RMpprev 05.04ConstipationWisner2001 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)26/25RR = 3.21 (1.55, 6.64)77%24%Likely (favouring control)Moderate
RMpprev 05.04Leaving study early due to adverse effectsWisner2001 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)26/25RR = 0.32 (0.01, 7.53)0%4%InconclusiveLow
RMpprev 05.02Recurrence of major depression postpartum (during trial, to 17 weeks postpartum)Wisner2001 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)26/25RR = 0.96 (0.36, 2.59)InconclusiveLow
RMpprev 05.03Recurrence of major depression postpartum (by 7-month follow-up) (including those who relapsed during 17-week trial)Wisner2001 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)26/25RR = 1.2 (0.57, 2.55)InconclusiveLow
Antidepressants (various) + monitoring versus monitoring
RMpprev 06.01Recurrence of major depression (DSM-III-R) within 3 months postpartumWisner1994 USASIGN: 2+ (−1)N/ARelevantSparse/imprecise data (−1)15/8RR = 0.11 (0.01, 0.76)Likely (favouring anti- depressants)Low
Sertraline versus placebo
RMpprev 07.02"Recurrence" of depression during drug trial (completer)Wisner2004 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)14/8RR = 0.14 (0.02, 1.07)Likely (favouring sertraline)Low
RMpprev 07.03"Recurrence" of depression during drug tapering (post-trial)Wisner2004 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)8/3RR = 2.22 (0.14, 36.49)InconclusiveLow
RMpprev 07.01Leaving study early for any reason except recurrenceWisner2004 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)17/8RR = 3.76 (0.56, 25.21)47%13%InconclusiveLow
RMpprev 07.04Dizziness reportedWisner2004 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)14/8RR = 4.57 (0.69, 30.22)57%13%InconclusiveLow
RMpprev 07.04Drowsiness reportedWisner2004 USASIGN: 1+N/ARelevantSparse/imprecise data (−1)14/8RR = 2 (1, 4)100%50%Likely (favouring control)Moderate
Maintaining medication versus decreasing medication (prophylaxis of existing major depression)
RMpproph 01.01Relapse (DSM-IV criteria) major depression during pregnancy (COHORT STUDY)Cohen2006 USASIGN: 2+ (−1)N/ARelevantSparse/imprecise data (−1)82/34RR = 0.73 (0.4, 1.3)26%35%InconclusiveLow
Maintaining medication versus discontinuing medication (prophylaxis of existing major depression)
RMpproph 02.0101 Relapse (DSM-IV criteria) major depression during pregnancy (COHORT STUDY)Cohen2006 USASIGN: 2+ (−1)N/ARelevantSparse/imprecise data (−1)82/65RR = 0.38 (0.25, 0.57)26%68%Very likely (favouring maintaining medication)Low

From: APPENDIX 19, EVIDENCE PROFILES

Cover of Antenatal and Postnatal Mental Health
Antenatal and Postnatal Mental Health: The NICE Guideline on Clinical Management and Service Guidance.
NICE Clinical Guidelines, No. 45.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2007.
Copyright © 2007, The British Psychological Society & The Royal College of Psychiatrists.

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