Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment

Obsessive Compulsive Disorder Clinical Trial

— EPMTOC  

Official title:

Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466609
• Other study ID #: 05/55628-8
• Secondary ID: 2005/55628-08
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2007
• Last updated: October 26, 2017
• Start date: May 2007
• Est. completion date: April 2010

Study information

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

Clinical Trial Summary

This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.

Description:

Arm 1: SSRI (Fluoxetine 40mg* once a day) + Clomipramine 75mg* once a day.

Arm 2: SSRI (Fluoxetine 40mg* once a day) + Quetiapine 200mg* once a day.

Arm 3: SSRI (Fluoxetine 80mg* once a day) + Placebo once a day.

*or maximum tolerated dose

We hypothesize that quetiapine and clomipramine will be effective augmentation strategies for resistant OCD patients in comparison to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. OCD diagnosis

2. YBOCS score = 16 (for patients with both obsessions and compulsions) or = 10 (for patients with only obsessions or compulsions)

3. Previously signed informed consent to participate in this clinical trial

Exclusion Criteria:

1. Patients with clinical or neurological diseases that may be worsen by the medications included in treatment protocol

2. Current substance dependence or abuse

3. Current psychotic symptoms

4. Current suicide risk

5. 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:
• Clomipramine (fluoxetine plus clomipramine)
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
• Quetiapine (fluoxetine plus quetiapine)
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
• Placebo (fluoxetine plus placebo)
Placebo plus fluoxetine at maximum dosage of 80mg per day

Locations

Country	Name	City	State
Brazil	Institute of Psychiatry	Sao Paulo	SP

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo, Novartis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	YBOCS	Rates of improvement after 12 weeks of treatment based on the difference of initial and final Yale Brown Obsessive Compulsive Scale (YBOCS) scores for obsessions and compulsions	12 weeks
Secondary	QoL	Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.	12 weeks
Secondary	Social Adaptation	Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12	12 weeks
Secondary	Tolerability	Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome)	weeks 0,1,2,3,4,8,12
Secondary	BDI	Score obtained with Beck depression inventory (BDI)	12 weeks
Secondary	BAI	Score obtained with Beck´s anxiety inventory (BAI)	12 weeks
Secondary	CGI	Clinical global impression measure of improvement	12 weeks
Secondary	Cardiotoxicity	Change from baseline EKG regarding QT interval	2 weeks
Secondary	Plasma levels	Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)	weeks 2 and 12

External Links

•   Institutional site of main sponsor
•   Main results
•   Secondary analysis results