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Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pioglitazone+Citalopram+Chlordiazepoxide
Placebo+ Citalopram+ Chlordiazepoxide
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, pioglitazone, double blind, placebo controlled

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pioglitazone+Citalopram+Chlordiazepoxide

Placebo+ Citalopram+ Chlordiazepoxide

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of Adverse events in each group
Scores of Hamilton Depression Rating Scale (17 items)

Full Information

First Posted
April 17, 2010
Last Updated
May 8, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01109030
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, pioglitazone, double blind, placebo controlled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone+Citalopram+Chlordiazepoxide
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo+ Citalopram+ Chlordiazepoxide
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pioglitazone+Citalopram+Chlordiazepoxide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo+ Citalopram+ Chlordiazepoxide
Intervention Description
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
Primary Outcome Measure Information:
Title
Scores of Hamilton Depression Rating Scale (17 items) at the end
Description
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)
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Number of Adverse events in each group
Time Frame
week 2,4,6
Title
Scores of Hamilton Depression Rating Scale (17 items)
Time Frame
week 0,2,4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahin Akhondzadeh, PhD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences
City
Tehran
ZIP/Postal Code
14479
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19411385
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.
Results Reference
background
PubMed Identifier
20191245
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.
Results Reference
background
PubMed Identifier
18579278
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.
Results Reference
background
PubMed Identifier
19745723
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.
Results Reference
background
PubMed Identifier
22549115
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.
Results Reference
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Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

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