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

University of Sao Paulo21 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obsessive Compulsive Disorder

Interventions

QuetiapineDRUG

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)

ClomipramineDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

YBOCS

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

Time frame: 12 weeks

Secondary Outcomes

CGI

Clinical Global Impression score for improvement at week 12

Time frame: 12 weeks

Tolerability

adverse events measure (emphasis in serotonergic syndrome)

Time frame: weeks 0,2,4,8 and 12

Cardiotoxicity

Changes in baseline (week 0) EKG regarding QT interval

Time frame: week 0 and 2

Data from ClinicalTrials.gov

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