Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Condition(s) targeted: Major Depressive Disorder

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

Phase: Phase 2/Phase 3

Status: Recruiting

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

Overall contact:
Amirhossein Modabbernia, M.D., Phone: 00982188287668, Email: Amirh899@gmail.com

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

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.

Criteria:

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

Amirhossein Modabbernia, M.D., Phone: 00982188287668, Email: Amirh899@gmail.com

Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences, Tehran 14479, Iran, Islamic Republic of; Recruiting
Shahin Akhondzadeh, PhD, Phone: 00982188281868, Email: S.akhond@neda.net
Amirhossein Modabbernia, M.D., Principal Investigator

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. No abstract available.

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.

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. Epub 2008 Jun 25.

Eissa Ahmed AA, Al-Rasheed NM, Al-Rasheed NM. Antidepressant-like effects of rosiglitazone, a PPARgamma agonist, in the rat forced swim and mouse tail suspension tests. Behav Pharmacol. 2009 Sep 9; [Epub ahead of print]

Starting date: April 2010
Last updated: February 15, 2011