Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-Compulsive Disorder Patients (QCAT)

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00564564
First received: November 26, 2007
Last updated: February 4, 2008
Last verified: February 2008

November 26, 2007
February 4, 2008
January 2006
December 2007   (final data collection date for primary outcome measure)
difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
percentage of reduction of initial Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00564564 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression score for improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • adverse events measure (emphasis in serotonergic syndrome) [ Time Frame: weeks 0,2,4,8 and 12 ] [ Designated as safety issue: Yes ]
  • Changes in baseline (week 0) EKG regarding QT interval [ Time Frame: week 0 and 2 ] [ Designated as safety issue: Yes ]
Clinical Global Impression score for improvement [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-Compulsive Disorder Patients
Quetiapine Augmentation Versus Clomipramine Augmentation of Selective Serotonin Reuptake Inhibitors for Obsessive-Compulsive Disorder Patients That do Not Respond to a SSRI Trial: a Randomized Open-Trial.

The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms.

The objective of this trial wis to compare in an randomized open trial format the efficacy of association of clomipramine at maximum dosage of 75mg per day and quetiapine at maximum dosage of 200mg per day with SSRI after SSRI treatment for 12 weeks failed to produce complete remission of OCD symptoms.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
  • Drug: Quetiapine
    Quetiapine once a day at maximum dosage of 200mg per day asociated to a SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
    Other Name: Seroquel
  • Drug: Clomipramine
    Clomipramine once a day at maximum dosage of 75mg per day plus SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
    Other Name: Anafranil
  • Experimental: 1
    Quetiapine plus SSRI
    Intervention: Drug: Quetiapine
  • Active Comparator: 2
    Clomipramine plus SSRI
    Intervention: Drug: Clomipramine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary OCD diagnosis according to DSM IV criteria
  • current symptoms were responsible for significant distress
  • previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms

Exclusion Criteria:

  • presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol
  • current substance dependence or abuse,
  • current psychotic symptoms
  • current suicide risk
  • and current pregnancy or intention to get pregnant before the end of the treatment protocol
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00564564
968/05, 2005/55628-08 (FAPESP)
Yes
Juliana Belo Diniz, University of São Paulo
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Juliana B Diniz, MD Department of Psychiatry University of São Paulo Medical School
University of Sao Paulo
February 2008

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