Evidence map›Paper›PMID 20581798›Full record

Trial reportPsychopharmacology bulletin2010

Predictors of non-stabilization during the combination therapy of lithium and divalproex in rapid cycling bipolar disorder: a post-hoc analysis of two studies.

Keming Gao, David E Kemp, Zuowei Wang, Stephen J Ganocy, Carla Conroy, Marry Beth Serrano, Martha Sajatovic, Robert L Findling, Joseph R Calabrese

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Psychopharmacology bulletin, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 100% 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

1 citing paper in PubMed, 12 citations in OpenAlex.

  1. Trial
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

9 authors at 2 institutions in 2 countries.

Keming GaoDepartment of Psychiatry, Case Western Reserve University, Cleveland, OH, USA. keming.gao@uhhospitals.org
David E Kemp
Zuowei Wang
Stephen J Ganocy
Carla Conroy
Marry Beth Serrano
Martha Sajatovic
Robert L Findling
Joseph R Calabrese
Case Western Reserve University · USShanghai Jiao Tong University · CN

Funding

Case Western Reserve University/Cleveland Clinic CTSA (KL2)KL2RR024990 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$9.5M
Psychosocial Intervention to Promote Treatment Adherence in CMCHP20MH066054 · NIMH · CASE WESTERN RESERVE UNIVERSITY · PI CALABRESE, JOSEPH R · 2003 to 2007
$2.7M
Combination Therapy in Bipolar Rapid CyclingR21MH062650 · NIMH · CASE WESTERN RESERVE UNIVERSITY · PI CALABRESE, JOSEPH R · 2002 to 2004
$574k
VALPROATE VERSUS LITHIUM IN BIPOLAR RAPID CYCLINGR01MH050165 · NIMH · CASE WESTERN RESERVE UNIVERSITY · PI CALABRESE, JOSEPH R · 1995 to 1999
–
NIMH NIH HHS P20 MH066054NIMH NIH HHS P20 MH-66054NIMH NIH HHS R01 MH050165NIMH NIH HHS R21 MH062650NIMH NIH HHS R21 MH-62650
6 · The paper itself

Abstract

objectiveTo study predictors of non-stabilization (i.e., not bimodally stabilized for randomization or not randomized due to premature discontinuation) during open-label treatment with lithium and divalproex in patients with rapid-cycling bipolar disorder (RCBD) with or without comorbid recent substance use disorders (SUDs).

methodData from the open-label phase of two maintenance studies were used. The reasons for non-stabilization were compared between patients with a recent SUD and those without. Predictors for non-stabilization were explored with logistic regression analyses.

resultsOf 149 patients with recent SUD and 254 without recent SUD enrolled into the open-label acute stabilization phase, 21% and 24% were stabilized and randomized, respectively. Compared to those without recent SUD, patients with recent SUD were more likely to discontinue the study due to non-adherence to the protocol, 53% versus 37% (OR = 1.92) or refractory mania/hypomania, 15% versus 9% (OR = 1.87), but less likely due to refractory depression 16% versus 25% (OR = 0.58) or adverse events, 10% versus19% (OR = 0.44). A history of recent SUDs, early life verbal abuse, female gender, and late onset of first depressive episode were associated with increased risk for non-stabilization with ORs of 1.85, 1.74, 1.10, and 1.04, respectively.

conclusionsDuring open treatment with lithium and divalproex in patients with RCBD, a recent SUD, a lifetime history of verbal abuse, female gender, and late onset of first depression independently predicted nonstabilization. The non-stabilization for patients with SUD was related to non-adherence and refractory mania/hypomania.

Indexed as

AdultAntimanic AgentsBipolar DisorderChi-Square DistributionComorbidityDouble-Blind MethodDrug Therapy, CombinationFemaleHumansLithium CompoundsLogistic ModelsMaleMedication AdherenceMiddle AgedOdds RatioPatient SelectionAntimanic AgentsLithium CompoundsValproic Acid

Identifiers

PMID20581798
PMCPMC3439803
OpenAlexW2288535419

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.