Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amirhossein Modabbernia, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01109030
First received: April 17, 2010
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Drug: Pioglitazone+Citalopram+Chlordiazepoxide
Drug: Placebo+ Citalopram+ Chlordiazepoxide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Scores of Hamilton Depression Rating Scale (17 items) at the end [ Time Frame: week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 2,4,6 ] [ Designated as safety issue: Yes ]
  • Scores of Hamilton Depression Rating Scale (17 items) [ Time Frame: week 0,2,4 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone+Citalopram+Chlordiazepoxide
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

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

Placebo Comparator: Placebo+ Citalopram+ Chlordiazepoxide

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

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


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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109030

Locations
Iran, Islamic Republic of
Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences
Tehran, Iran, Islamic Republic of, 14479
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Shahin Akhondzadeh, PhD Tehran University of Medical Sciences
  More Information

Publications:
Responsible Party: Amirhossein Modabbernia, Dr Amirhossein Modabbernia, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01109030     History of Changes
Other Study ID Numbers: 94976
Study First Received: April 17, 2010
Last Updated: May 8, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Major depressive disorder
pioglitazone
double blind
placebo controlled

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Pioglitazone
Citalopram
Dexetimide
Chlordiazepoxide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014