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Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Pioglitazone+Citalopram+Chlordiazepoxide (Drug); Placebo+ Citalopram+ Chlordiazepoxide (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Tehran University of Medical Sciences

Official(s) and/or principal investigator(s):
Shahin Akhondzadeh, PhD, Study Chair, Affiliation: Tehran University of Medical Sciences


The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is effective in treatment of moderate to severe depression

Clinical Details

Official title: Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Scores of Hamilton Depression Rating Scale (17 items) at the end

Secondary outcome:

Number of Adverse events in each group

Scores of Hamilton Depression Rating Scale (17 items)

Detailed description: Pioglitazone as a Ppar-gamma agonist is an anti diabetic drug. It was also shown that, it has certain anti inflammatory and neuro-protective effects. In recent years it has been proposed that Ppar-gamma agonists may have effects on mood and cognition. In animal studies and in one human case report as well as a pilot study on human subjects these drugs improved symptoms of depression. A randomized controlled and double blind design will provide further evidence for the efficacy of these drugs in major depressive disorder.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of Major depressive disorder based on DSM-IV TR criteria

- Age 18-50

- Hamilton Depression Rating scale >=22

- Signing the informed consent form

- Citalopram be the drug of choice for the patient irrespective of other eligibility

criteria Exclusion Criteria:

- Problems in other Axes

- Pregnancy and lactation

- Serious or life threatening disease

- taking other antidepressant in the recent month or Electroconvulsive shock in the

recent two months, and taking other psychotropic agents

- Diabetes controlled with drugs or insulin (patients with only lifestyle interventions

will be included), Liver disease, Congestive heart failure Class III and IV

- Metabolic syndrome

Locations and Contacts

Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences, Tehran 14479, Iran, Islamic Republic of
Additional Information

Related publications:

Kemp DE, Ismail-Beigi F, Calabrese JR. Antidepressant response associated with pioglitazone: support for an overlapping pathophysiology between major depression and metabolic syndrome. Am J Psychiatry. 2009 May;166(5):619. doi: 10.1176/appi.ajp.2008.08081195.

Rasgon NL, Kenna HA, Williams KE, Powers B, Wroolie T, Schatzberg AF. Rosiglitazone add-on in treatment of depressed patients with insulin resistance: a pilot study. ScientificWorldJournal. 2010 Feb 19;10:321-8. doi: 10.1100/tsw.2010.32.

Rosa AO, Kaster MP, Binfaré RW, Morales S, Martín-Aparicio E, Navarro-Rico ML, Martinez A, Medina M, García AG, López MG, Rodrigues AL. Antidepressant-like effect of the novel thiadiazolidinone NP031115 in mice. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Aug 1;32(6):1549-56. doi: 10.1016/j.pnpbp.2008.05.020. Epub 2008 Jun 25.

Eissa Ahmed AA, Al-Rasheed NM, Al-Rasheed NM. Antidepressant-like effects of rosiglitazone, a PPARγ agonist, in the rat forced swim and mouse tail suspension tests. Behav Pharmacol. 2009 Oct;20(7):635-42. doi: 10.1097/FBP.0b013e328331b9bf.

Starting date: April 2010
Last updated: May 8, 2012

Page last updated: August 23, 2015

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