Evidence map›Paper›PMID 26143402›Full record

Trial reportJournal of affective disorders2015

Safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for relapse-prevention of bipolar II depression: A randomized, double-blind, parallel-group, prospective study.

Jay D Amsterdam, Lorenzo Lorenzo-Luaces, Irene Soeller, Susan Qing Li, Jun J Mao, Robert J DeRubeis

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of affective disorders, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
6.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Lithium treatment of Bipolar disorder in adults: A systematic review of randomized trials and meta-analyses.European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2022
    Pooled it
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  14. Antidepressants in bipolar depression: an enduring controversy.International journal of bipolar disorders · 2018
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Jay D AmsterdamDepression Research Unit, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania School of Medicine, Philadelphia, PA, USA. Electronic address: jamsterd@mail.med.upenn.edu.
Lorenzo Lorenzo-LuacesDepression Research Unit, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania School of Medicine, Philadelphia, PA, USA; Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.
Irene SoellerDepression Research Unit, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania School of Medicine, Philadelphia, PA, USA; Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Susan Qing LiDepression Research Unit, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania School of Medicine, Philadelphia, PA, USA; Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Jun J MaoDepartment of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Robert J DeRubeisDepression Research Unit, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania School of Medicine, Philadelphia, PA, USA; Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.
University of Pennsylvania · US

Funding

Treatment of Bipolar Type II Major DepressionR01MH060353 · NIMH · UNIVERSITY OF PENNSYLVANIA · PI DERUBEIS, ROBERT J · 2001 to 2011
$3.9M
1/2-Prevention of Relapse & Recurrence of Bipolar DepressionR01MH080097 · NIMH · UNIVERSITY OF PENNSYLVANIA · PI DERUBEIS, ROBERT J · 2009 to 2013
$2.0M
NIMH NIH HHS R01 MH060353NIMH NIH HHS R01 MH080097
6 · The paper itself

Abstract

objectiveCompare the safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for preventing depressive relapse in bipolar II disorder.

methodsSubjects ≥18 years old with bipolar II depression (n=129) were randomized to double-blind venlafaxine or lithium monotherapy for 12 weeks. Responders with a ≥50% reduction in depression score were continued for an additional 6 months of relapse-prevention monotherapy. Primary outcome was depressive relapse during continuation monotherapy. Secondary outcomes included sustained response rate from initiation of treatment to study end-point, relapse hazard, time to relapse, change in mania ratings, and frequency of treatment-emergent sub-syndromal hypomania and/or depressive episodes.

resultsVenlafaxine produced greater sustained response rate versus lithium (p<0.0001); however, there was no difference in relapse rate for venlafaxine (7.5%) versus lithium (26.7%) (p=0.079); relapse hazard (p=0.073), or time to relapse (p=0.090) between treatment conditions during continuation monotherapy. There were no group differences in mania rating scores over time and no difference in frequency or duration of syndromal or sub-syndromal hypomanic episodes. There were more sub-syndromal depressive episodes during lithium monotherapy (p=0.03). LIMITATIONS: Sample size was limited by the lower sustained response rate for lithium versus venlafaxine; study was not specifically powered to detect differences in treatment-emergent hypomanic or depressive episodes between groups.

conclusionResults suggest that continuation venlafaxine monotherapy may provide similar prophylactic effectiveness relative to lithium, with no difference in treatment-emergent hypomanic episodes and without the need for frequent serum lithium level and metabolic monitoring. Larger, prospective trials are needed to confirm these observations.

Indexed as

AdultAntidepressive AgentsAntipsychotic AgentsBipolar DisorderDouble-Blind MethodFemaleHumansLithium CompoundsMaleProspective StudiesSecondary PreventionTreatment OutcomeVenlafaxine HydrochlorideAntidepressive AgentsAntipsychotic AgentsLithium CompoundsVenlafaxine HydrochlorideAntidepressantBipolar II depressionBipolar II disorderClinical trial. ClinicalTrials.gov identifier: NCT00602537LithiumMood conversionRelapse-preventionVenlafaxine

Identifiers

PMID26143402
PMCPMC4540653
OpenAlexW1564492230

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.