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

Tracking Information

First Received Date ^ICMJE

April 26, 2007

Last Updated Date

June 5, 2009

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Rates of improvement after 12 weeks of treatment based on the percent reduction of initial Yale Brown Obsessive Compulsive Scale (YBOCS) scores for obsessions and compulsions.

Change History

Complete list of historical versions of study NCT00466609 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome) [ Time Frame: weeks 0,1,2,3,4,8,12 ] [ Designated as safety issue: Yes ]
Score obtained with Beck depression inventory (BDI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Score obtained with Beck´s anxiety inventory (BAI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clinical global impression measure of improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline EKG regarding QT interval [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Fluoxetine dosage and Clomipramine dosage (when applies) [ Time Frame: weeks 2 and 12 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12;
Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12;
Tolerability of the proposed treatments through adverse events follow-up performed each visit (weeks 0,2,4,8,12).

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder (OCD). The investigators will compare the association of an SSRI (fluoxetine) with quetiapine, Selective serotonin reuptake inhibitors (SSRI) with clomipramine and SSRI with placebo for 12 weeks.

Detailed 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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obsessive Compulsive Disorder

Intervention ^ICMJE

Drug: clomipramine and fluoxetine
Drug: quetiapine and fluoxetine
Drug: placebo and fluoxetine

Study Arms / Comparison Groups

Experimental: fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks
Experimental: Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
Placebo Comparator: Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks

Publications *

Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

OCD diagnosis
YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)
Previously signed informed consent to participate in this clinical trial

Exclusion Criteria:

Patients with 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
Current pregnancy or intention to get pregnant before the end of the treatment protocol

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marines Joaquim, Nurse	5511 30696972 ext 169	majoaquim.protoc@gmail.com
Contact: Juliana Diniz, MD	5511 30696972 ext 170	juliana@protoc.com.br

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00466609

Responsible Party

Juliana Belo Diniz, University of São Paulo

Study ID Numbers ^ICMJE

05/55628-8, 2005/55628-08

Study Sponsor ^ICMJE

University of Sao Paulo

Collaborators ^ICMJE

Fundação de Amparo à Pesquisa do Estado de São Paulo
CNPq
Novartis

Investigators ^ICMJE

Principal Investigator:

Juliana B Diniz, MD

University of Sao Paulo Medical School

Information Provided By

University of Sao Paulo

Verification Date

June 2009

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