Clinical trial NCT01109030: Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder
Official title: Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
pioglitazone
double blind
placebo controlled
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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
* Metabolic syndrome

Primary outcomes:
measure: Scores of Hamilton Depression Rating Scale (17 items) at the end
timeFrame: week 6
Secondary outcomes:
measure: Number of Adverse events in each group
timeFrame: week 2,4,6
measure: Scores of Hamilton Depression Rating Scale (17 items)
timeFrame: week 0,2,4
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Shahin Akhondzadeh, PhD
role: STUDY_CHAIR
References:
citation: 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. No abstract available.
citation: 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.
citation: Rosa AO, Kaster MP, Binfare RW, Morales S, Martin-Aparicio E, Navarro-Rico ML, Martinez A, Medina M, Garcia AG, Lopez 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.
citation: 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 Oct;20(7):635-42. doi: 10.1097/FBP.0b013e328331b9bf.
citation: Sepanjnia K, Modabbernia A, Ashrafi M, Modabbernia MJ, Akhondzadeh S. Pioglitazone adjunctive therapy for moderate-to-severe major depressive disorder: randomized double-blind placebo-controlled trial. Neuropsychopharmacology. 2012 Aug;37(9):2093-100. doi: 10.1038/npp.2012.58. Epub 2012 May 2.