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

Obsessive Compulsive Disorder Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564564
• Other study ID #: 968/05
• Secondary ID: 2005/55628-08
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2007
• Last updated: October 25, 2017
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: October 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

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)
• 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)

Locations

Country	Name	City	State
Brazil	Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. Epub 2006 Apr 4. Review. Erratum in: Mol Psychiatry. 2006 Aug;11(8):795. — View 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. — View 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. — View 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. — View Citation

Pallanti S, Quercioli L, Paiva RS, Koran LM. Citalopram for treatment-resistant obsessive-compulsive disorder. Eur Psychiatry. 1999 Apr;14(2):101-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	YBOCS	difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score	12 weeks
Secondary	CGI	Clinical Global Impression score for improvement at week 12	12 weeks
Secondary	Tolerability	adverse events measure (emphasis in serotonergic syndrome)	weeks 0,2,4,8 and 12
Secondary	Cardiotoxicity	Changes in baseline (week 0) EKG regarding QT interval	week 0 and 2

External Links

•   institutional site
•   Mains results