Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 90 of 561 for:    ESCITALOPRAM AND Disorders

Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01109030
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : May 9, 2012
Sponsor:
Information provided by (Responsible Party):
Amirhossein Modabbernia, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE April 17, 2010
First Posted Date  ICMJE April 22, 2010
Last Update Posted Date May 9, 2012
Study Start Date  ICMJE April 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2010)
Scores of Hamilton Depression Rating Scale (17 items) at the end [ Time Frame: week 6 ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2012)
  • Number of Adverse events in each group [ Time Frame: week 2,4,6 ]
  • Scores of Hamilton Depression Rating Scale (17 items) [ Time Frame: week 0,2,4 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2010)
  • Number of Adverse events in each group [ Time Frame: week 1,2,4,6 ]
  • Scores of Hamilton Depression Rating Scale (17 items) [ Time Frame: week 0,1,2,4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder
Official Title  ICMJE Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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

  • 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

Study Arms  ICMJE
  • 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
    Intervention: Drug: Pioglitazone+Citalopram+Chlordiazepoxide
  • 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.

    Intervention: Drug: Placebo+ Citalopram+ Chlordiazepoxide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2012)
50
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2010)
40
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01109030
Other Study ID Numbers  ICMJE 94976
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amirhossein Modabbernia, Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shahin Akhondzadeh, PhD Tehran University of Medical Sciences
PRS Account Tehran University of Medical Sciences
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP