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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00564564
• Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder	Drug: Quetiapine; Drug: Clomipramine	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quetiapine augmentation Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage	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 Names: Seroquel
Active Comparator: Clomipramine augmentation Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage	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 Names: Anafranil

Outcome Measures

Primary Outcome Measures

1. YBOCS [12 weeks]

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

Secondary Outcome Measures

1. CGI [12 weeks]

   Clinical Global Impression score for improvement at week 12

2. Tolerability [weeks 0,2,4,8 and 12]

   adverse events measure (emphasis in serotonergic syndrome)

3. Cardiotoxicity [week 0 and 2]

   Changes in baseline (week 0) EKG regarding QT interval

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School	São Paulo	SP	Brazil	05403-010

Sponsors and Collaborators

• University of Sao Paulo
• Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

• Principal Investigator: Juliana B Diniz, MD, Department of Psychiatry University of São Paulo Medical School

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• institutional site
• Mains results

Publications

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

• Responsible Party: Juliana Belo Diniz, MD, PhD, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT00564564
• Other Study ID Numbers: 968/05; 2005/55628-08
• First Posted: Nov 28, 2007
• Last Update Posted: Oct 27, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Juliana Belo Diniz, MD, PhD, University of Sao Paulo: obsessive compulsive disorder; pharmacological treatment; quetiapine; clomipramine; SSRI
• Additional relevant MeSH terms: Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Quetiapine Fumarate; Clomipramine

Study Results

No Results Posted as of Oct 27, 2017