Pharmacological Augmentation Strategies for OCD Patients: A Double-Blind Placebo Controlled Study.

Condition(s) targeted: Obsessive Compulsive Disorder

Intervention: Association of clomipramine and fluoxetine (Drug); Association of quetiapine and fluoxetine (Drug); Association of placebo and fluoxetine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Juliana B Diniz, MD, Principal Investigator, Affiliation: University of Sao Paulo Medical School

Overall contact:
Izabel Pimentel, Nurse, Phone: 5511 30696972, Ext: 169, Email: izabelpimentel@terra.com.br

This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for OCD. We will compare the association of an SSRI with quetiapine, SSRI with clomipramine and SSRI with placebo for 12 weeks.

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

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

Primary outcome:

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.

Clinical Global impression score for improvement

Secondary outcome:

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).

Reduction of Beck depression scale

reduction of Beck anxiety scale

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Izabel Pimentel, Nurse, Phone: 5511 30696972, Ext: 169, Email: izabelpimentel@terra.com.br

Institute of Psychiatry, Sao Paulo, SP 05403-010, Brazil; Recruiting

Main research group involved in this study

Institutional site of main sponsor

Starting date: May 2007
Ending date: June 2009
Last updated: November 26, 2007