Evidence map›Paper›PMID 21782251›Full record

Trial reportJournal of affective disorders2012

Use of insulin sensitizers for the treatment of major depressive disorder: a pilot study of pioglitazone for major depression accompanied by abdominal obesity.

David E Kemp, Faramarz Ismail-Beigi, Stephen J Ganocy, Carla Conroy, Keming Gao, Sarah Obral, Elizabeth Fein, Robert L Findling, Joseph R Calabrese

Abstract readClinical Trial
In one paragraph

Trial report in Journal of affective disorders, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 5% 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

53 citing papers in PubMed, 1 synthesis or guideline pooled it, 103 citations in OpenAlex.

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  8. Pioglitazone adjunctive therapy for moderate-to-severe major depressive disorder: randomized double-blind placebo-controlled trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2012
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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

9 authors at 2 institutions in 1 country.

David E KempCase Western Reserve University, University Hospitals Case Medical Center, Department of Psychiatry, Cleveland, OH 44106, USA. kemp.david@gmail.com
Faramarz Ismail-Beigi
Stephen J Ganocy
Carla Conroy
Keming Gao
Sarah Obral
Elizabeth Fein
Robert L Findling
Joseph R Calabrese
University Hospitals Case Medical Center · USCase Western Reserve University · US

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
Case Western Reserve University/Cleveland Clinic CTSA (KL2)KL2RR024990 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$9.5M
Training Program in Social DevelopmentT32HD007542 · NICHD · UNIV OF MARYLAND, COLLEGE PARK · PI KILLEN, MELANIE ANN · 2003 to 2015
$1.9M
NCRR NIH HHS 1KL2RR024990NCRR NIH HHS KL2 RR024990NCRR NIH HHS UL1 RR024989NICHD NIH HHS T32 HD007542
6 · The paper itself

Abstract

objectiveThis study was conducted to examine the safety and efficacy of pioglitazone, a thiazolidinedione insulin sensitizer, in adult outpatients with major depressive disorder.

methodIn a 12-week, open-label, flexible-dose study, 23 patients with major depressive disorder received pioglitazone monotherapy or adjunctive therapy initiated at 15 mg daily. Subjects were required to meet criteria for abdominal obesity (waist circumference>35 in. in women and >40 in. in men) or metabolic syndrome. The primary efficacy measure was the change from baseline to Week 12 on the Inventory of Depressive Symptomatology (IDS) total score. Partial responders (≥25% decrease in IDS total score) were eligible to participate in an optional extension phase for an additional three months.

resultsPioglitazone decreased depression symptom severity from a total IDS score of 40.3±1.8 to 19.2±1.8 at Week 12 (p<.001). Among partial responders (≥25% decrease in IDS total score), an improvement in depressive symptoms was maintained during an additional 3-month extension phase (total duration=24 weeks) according to IDS total scores (p<.001). Patients experienced a reduction in insulin resistance from baseline to Week 12 according to the log homeostasis model assessment (-0.8±0.75; p<.001) and a significant reduction in inflammation as measured by log highly- sensitive C-reactive protein (-0.87±0.72; p<.001). During the current episode, the majority of participants (74%, n=17), had already failed at least one antidepressant trial. The most common side effects were headache and dizziness; no patient discontinued due to side effects. LIMITATIONS: These data are limited by a small sample size and an open-label study design with no placebo control.

conclusionAlthough preliminary, pioglitazone appears to reduce depression severity and improve several markers of cardiometabolic risk, including insulin resistance and inflammation. Larger, placebo-controlled studies are indicated.

Indexed as

AdultAntidepressive AgentsDouble-Blind MethodFemaleHumansHypoglycemic AgentsMajor Depressive DisorderMaleMetabolic SyndromeMiddle AgedObesity, AbdominalPersonality InventoryPilot ProjectsPioglitazoneThiazolidinedionesAntidepressive AgentsHypoglycemic AgentsPioglitazoneThiazolidinediones

Identifiers

PMID21782251
PMCPMC3225727
OpenAlexW2160313172

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.