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

University of Sao Paulo54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obsessive Compulsive Disorder

Interventions

Clomipramine (fluoxetine plus clomipramine)DRUG

Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day

Quetiapine (fluoxetine plus quetiapine)DRUG

Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day

Placebo (fluoxetine plus placebo)DRUG

Placebo plus fluoxetine at maximum dosage of 80mg per day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Psychiatry

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

QoL

Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.

Time frame: 12 weeks

Social Adaptation

Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman \& Payket, 1974) administered on weeks 0 and 12

Time frame: 12 weeks

Tolerability

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

BDI

Score obtained with Beck depression inventory (BDI)

Time frame: 12 weeks

BAI

Score obtained with Beck´s anxiety inventory (BAI)

Time frame: 12 weeks

CGI

Clinical global impression measure of improvement

Time frame: 12 weeks

Cardiotoxicity

Change from baseline EKG regarding QT interval

Time frame: 2 weeks

Plasma levels

Data from ClinicalTrials.gov

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