Clinical trial NCT00466609: Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment
Official title: Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Keywords: clomipramine
quetiapine
fluoxetine
placebo
augmentation
obsessive compulsive disorder
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Novartis
First posted: 2007-04-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: YBOCS
timeFrame: 12 weeks
Secondary outcomes:
measure: QoL
timeFrame: 12 weeks
measure: Social Adaptation
timeFrame: 12 weeks
measure: Tolerability
timeFrame: weeks 0,1,2,3,4,8,12
measure: BDI
timeFrame: 12 weeks
measure: BAI
timeFrame: 12 weeks
measure: CGI
timeFrame: 12 weeks
measure: Cardiotoxicity
timeFrame: 2 weeks
measure: Plasma levels
timeFrame: weeks 2 and 12
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Psychiatry
state: SP
Study officials:
affiliation: University of Sao Paulo Medical School
name: Juliana B Diniz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diniz JB, Shavitt RG, Fossaluza V, Koran L, Pereira CA, Miguel EC. A double-blind, randomized, controlled trial of fluoxetine plus quetiapine or clomipramine versus fluoxetine plus placebo for obsessive-compulsive disorder. J Clin Psychopharmacol. 2011 Dec;31(6):763-8. doi: 10.1097/JCP.0b013e3182367aee.
citation: Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8. doi: 10.1590/s1807-59322009000600005.