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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Quetiapine Augmentation Versus Clomipramine Augmentation of Selective Serotonin Reuptake Inhibitors for Obsessive-compulsive Disorder Patients That do Not Respond to a SSRI Trial: a Randomized Open-trial.

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine
* Drug: Clomipramine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quetiapine augmentation<br>Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage | Drug: Quetiapine<br>* 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)<br>* Other names: Seroquel;|
| Active Comparator: Clomipramine augmentation<br>Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage | Drug: Clomipramine<br>* 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)<br>* Other names: Anafranil;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YBOCS | difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI | Clinical Global Impression score for improvement at week 12 | 12 weeks | 
| Tolerability | adverse events measure (emphasis in serotonergic syndrome) | weeks 0,2,4,8 and 12 | 
| Cardiotoxicity | Changes in baseline (week 0) EKG regarding QT interval | week 0 and 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obsessive compulsive disorder, pharmacological treatment, quetiapine, clomipramine, SSRI