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

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Obsessive Compulsive Disorder

Treatments: Drug: Placebo (fluoxetine plus placebo); Drug: Quetiapine (fluoxetine plus quetiapine); Drug: Clomipramine (fluoxetine plus clomipramine)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00466609

2005/55628-08 (Other Grant/Funding Number)

05/55628-8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups, including a placebo group

Quetiapine (fluoxetine plus quetiapine)

Experimental group

Description:

fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks

Treatment:

Drug: Quetiapine (fluoxetine plus quetiapine)

Clomipramine (fluoxetine plus clomipramine)

Active Comparator group

Description:

Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks

Treatment:

Drug: Clomipramine (fluoxetine plus clomipramine)

Placebo (fluoxetine plus placebo)

Placebo Comparator group

Description:

Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks

Treatment:

Drug: Placebo (fluoxetine plus placebo)