Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment
Information source: University of Sao Paulo
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive Compulsive Disorder
Intervention: clomipramine and fluoxetine (Drug); quetiapine and fluoxetine (Drug); placebo and fluoxetine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s):
Juliana B Diniz, MD, Principal Investigator, Affiliation: University of Sao Paulo Medical School
Overall contact:
Marines Joaquim, Nurse, Phone: 5511 30696972, Ext: 169, Email: majoaquim.protoc@gmail.com
Summary
This will be a controlled, randomized, double-blind and double-dummy study on the treatment
augmentation strategy for obsessive compulsive disorder (OCD). The investigators will
compare the association of an SSRI (fluoxetine) with quetiapine, Selective serotonin
reuptake inhibitors (SSRI) with clomipramine and SSRI with placebo for 12 weeks.
Clinical Details
Official title: Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-Respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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 outcome: Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12;Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12 Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome) Score obtained with Beck depression inventory (BDI) Score obtained with Beck´s anxiety inventory (BAI) Clinical global impression measure of improvement Change from baseline EKG regarding QT interval Fluoxetine dosage and Clomipramine dosage (when applies)
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Marines Joaquim, Nurse, Phone: 5511 30696972, Ext: 169, Email: majoaquim.protoc@gmail.com
Institute of Psychiatry, Sao Paulo, SP 05403-010, Brazil; Recruiting
Additional Information
Main research group involved in this study Institutional site of main sponsor
Starting date: May 2007
Ending date: June 2010
Last updated: June 5, 2009
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