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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00564564

Acronym

QCAT

Enrollment

Registered

2007-11-28

Start date

2006-01-31

Completion date

2007-12-31

Last updated

2017-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder

Keywords

obsessive compulsive disorder, pharmacological treatment, quetiapine, clomipramine, SSRI

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.

Interventions

DRUGQuetiapine

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)

DRUGClomipramine

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026