Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment
NCT ID: NCT00466609
Last Updated: 2017-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
54 participants
INTERVENTIONAL
2007-05-31
2010-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Quetiapine (fluoxetine plus quetiapine)
fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks
Quetiapine (fluoxetine plus quetiapine)
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
Clomipramine (fluoxetine plus clomipramine)
Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
Clomipramine (fluoxetine plus clomipramine)
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
Placebo (fluoxetine plus placebo)
Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks
Placebo (fluoxetine plus placebo)
Placebo plus fluoxetine at maximum dosage of 80mg per day
Interventions
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Clomipramine (fluoxetine plus clomipramine)
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
Quetiapine (fluoxetine plus quetiapine)
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
Placebo (fluoxetine plus placebo)
Placebo plus fluoxetine at maximum dosage of 80mg per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Novartis
INDUSTRY
University of Sao Paulo
OTHER
Responsible Party
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Juliana Belo Diniz
MD, PhD
Principal Investigators
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Juliana B Diniz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo Medical School
Locations
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Institute of Psychiatry
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
Related Links
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Institutional site of main sponsor
Main results
Secondary analysis results
Other Identifiers
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2005/55628-08
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
05/55628-8
Identifier Type: -
Identifier Source: org_study_id