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

Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00466609

Acronym

EPMTOC

Enrollment

Registered

2007-04-27

Start date

2007-05-31

Completion date

2010-04-30

Last updated

2017-10-30

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

Conditions

Obsessive Compulsive Disorder

Keywords

clomipramine, quetiapine, fluoxetine, placebo, augmentation, obsessive compulsive disorder

Brief summary

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.

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.

Interventions

DRUGClomipramine (fluoxetine plus clomipramine)

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

DRUGQuetiapine (fluoxetine plus quetiapine)

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

DRUGPlacebo (fluoxetine plus placebo)

Placebo plus fluoxetine at maximum dosage of 80mg per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
YBOCS	12 weeks	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

Secondary

Measure	Time frame	Description
QoL	12 weeks	Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.
Social Adaptation	12 weeks	Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12
Tolerability	weeks 0,1,2,3,4,8,12	Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome)
BDI	12 weeks	Score obtained with Beck depression inventory (BDI)
BAI	12 weeks	Score obtained with Beck´s anxiety inventory (BAI)
CGI	12 weeks	Clinical global impression measure of improvement
Cardiotoxicity	2 weeks	Change from baseline EKG regarding QT interval
Plasma levels	weeks 2 and 12	Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026