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

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Quetiapine
Clomipramine
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring obsessive compulsive disorder, pharmacological treatment, quetiapine, clomipramine, SSRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quetiapine augmentation

Clomipramine augmentation

Arm Description

Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage

Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage

Outcomes

Primary Outcome Measures

YBOCS
difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score

Secondary Outcome Measures

CGI
Clinical Global Impression score for improvement at week 12
Tolerability
adverse events measure (emphasis in serotonergic syndrome)
Cardiotoxicity
Changes in baseline (week 0) EKG regarding QT interval

Full Information

First Posted
November 26, 2007
Last Updated
October 25, 2017
Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT00564564
Brief Title
Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients
Acronym
QCAT
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
obsessive compulsive disorder, pharmacological treatment, quetiapine, clomipramine, SSRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine augmentation
Arm Type
Experimental
Arm Description
Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage
Arm Title
Clomipramine augmentation
Arm Type
Active Comparator
Arm Description
Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Clomipramine
Other Intervention Name(s)
Anafranil
Intervention Description
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)
Primary Outcome Measure Information:
Title
YBOCS
Description
difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
CGI
Description
Clinical Global Impression score for improvement at week 12
Time Frame
12 weeks
Title
Tolerability
Description
adverse events measure (emphasis in serotonergic syndrome)
Time Frame
weeks 0,2,4,8 and 12
Title
Cardiotoxicity
Description
Changes in baseline (week 0) EKG regarding QT interval
Time Frame
week 0 and 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana B Diniz, MD
Organizational Affiliation
Department of Psychiatry University of São Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16585942
Citation
Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. doi: 10.1038/sj.mp.4001823. Epub 2006 Apr 4. Erratum In: Mol Psychiatry. 2006 Aug;11(8):795.
Results Reference
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PubMed Identifier
8518974
Citation
Browne M, Horn E, Jones TT. The benefits of clomipramine-fluoxetine combination in obsessive compulsive disorder. Can J Psychiatry. 1993 May;38(4):242-3. doi: 10.1177/070674379303800402.
Results Reference
background
PubMed Identifier
15323587
Citation
Denys D, de Geus F, van Megen HJ, Westenberg HG. A double-blind, randomized, placebo-controlled trial of quetiapine addition in patients with obsessive-compulsive disorder refractory to serotonin reuptake inhibitors. J Clin Psychiatry. 2004 Aug;65(8):1040-8. doi: 10.4088/jcp.v65n0803.
Results Reference
background
PubMed Identifier
15933483
Citation
Fineberg NA, Sivakumaran T, Roberts A, Gale T. Adding quetiapine to SRI in treatment-resistant obsessive-compulsive disorder: a randomized controlled treatment study. Int Clin Psychopharmacol. 2005 Jul;20(4):223-6. doi: 10.1097/00004850-200507000-00005.
Results Reference
background
PubMed Identifier
10572334
Citation
Pallanti S, Quercioli L, Paiva RS, Koran LM. Citalopram for treatment-resistant obsessive-compulsive disorder. Eur Psychiatry. 1999 Apr;14(2):101-6. doi: 10.1016/s0924-9338(99)80725-1.
Results Reference
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Links:
URL
http://www.ipqhc.org.br/
Description
institutional site
URL
https://www.ncbi.nlm.nih.gov/pubmed/19164490
Description
Mains results

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Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients

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