Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

NCT01109030 | Completed Phase 2 DMC

• 1 other identifier: 94976
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; pioglitazone; double blind; placebo controlled

Outcome Measures

Primary Outcomes (1)

• Scores of Hamilton Depression Rating Scale (17 items) at the end

  Hamilton Depression rating scale is a 17-item scale. The questionnaire rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. The questionnaire is presently one of the most commonly used scales for rating depression in medical research. The primary outcome measure is Scores on Hamilton Depression Rating Scale at the end (week 6)

  week 6

Secondary Outcomes (2)

• Number of Adverse events in each group

  week 2,4,6

• Scores of Hamilton Depression Rating Scale (17 items)

  week 0,2,4

Study Arms (2)

Pioglitazone+Citalopram+Chlordiazepoxide

ACTIVE COMPARATOR

Pioglitazone 15 mg Q12h will be given to the patients in active comparator group for 6 weeks. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks.Chlordiazepoxide 10 mg/day for first three weeks

Drug: Pioglitazone+Citalopram+Chlordiazepoxide

Placebo+ Citalopram+ Chlordiazepoxide

PLACEBO COMPARATOR

Placebo 1 Q12h for 6 weeks with the same shape and color as Pioglitazone. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks. Chlordiazepoxide 10 mg each night for first three weeks.

Drug: Placebo+ Citalopram+ Chlordiazepoxide

Interventions

Pioglitazone+Citalopram+Chlordiazepoxide DRUG

Pioglitazone 15 mg every 12 hours for six weeks Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks. Chlordiazepoxide 10 mg each night for first three weeks

Pioglitazone+Citalopram+Chlordiazepoxide

Placebo+ Citalopram+ Chlordiazepoxide DRUG

Placebo 1 Q12h for 6 weeks with the same shape and color as Pioglitazone. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks. Chlordiazepoxide 10 mg each night for first three weeks

Placebo+ Citalopram+ Chlordiazepoxide

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences

Tehran, Tehran Province, 14479, Iran

Location

Related Publications (5)

• 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.

  PMID: 19411385 BACKGROUND

• 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.

  PMID: 20191245 BACKGROUND

• 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.

  PMID: 18579278 BACKGROUND

• 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.

  PMID: 19745723 BACKGROUND

• 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.

  PMID: 22549115 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Shahin Akhondzadeh, PhD

  Tehran University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Amirhossein Modabbernia

Study Record Dates

• First Submitted: April 17, 2010
• First Posted: April 22, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 9, 2012

Record last verified: 2012-05

Locations

IR (1)