Back to resultsUsing Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment (EPMTOC)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Clomipramine (fluoxetine plus clomipramine)
Quetiapine (fluoxetine plus quetiapine)
Placebo (fluoxetine plus placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring clomipramine, quetiapine, fluoxetine, placebo, augmentation, obsessive compulsive disorder
Eligibility Criteria
Inclusion Criteria:
- OCD diagnosis
- YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)
- Previously signed informed consent to participate in this clinical trial
Exclusion Criteria:
- Patients with clinical or neurological diseases that may be worsen by the medications included in treatment protocol
- Current substance dependence or abuse
- Current psychotic symptoms
- Current suicide risk
- Current pregnancy or intention to get pregnant before the end of the treatment protocol
Sites / Locations
- Institute of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Quetiapine (fluoxetine plus quetiapine)
Clomipramine (fluoxetine plus clomipramine)
Placebo (fluoxetine plus placebo)
Arm Description
fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks
Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks
Outcomes
Primary Outcome Measures
YBOCS
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 Measures
QoL
Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.
Social Adaptation
Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12
Tolerability
Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome)
BDI
Score obtained with Beck depression inventory (BDI)
BAI
Score obtained with Beck´s anxiety inventory (BAI)
CGI
Clinical global impression measure of improvement
Cardiotoxicity
Change from baseline EKG regarding QT interval
Plasma levels
Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)
Full Information
NCT ID
NCT00466609
First Posted
April 26, 2007
Last Updated
October 26, 2017
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00466609
Brief Title
Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment
Acronym
EPMTOC
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
clomipramine, quetiapine, fluoxetine, placebo, augmentation, obsessive compulsive disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quetiapine (fluoxetine plus quetiapine)
Arm Type
Experimental
Arm Description
fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks
Arm Title
Clomipramine (fluoxetine plus clomipramine)
Arm Type
Active Comparator
Arm Description
Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
Arm Title
Placebo (fluoxetine plus placebo)
Arm Type
Placebo Comparator
Arm Description
Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks
Intervention Type
Drug
Intervention Name(s)
Clomipramine (fluoxetine plus clomipramine)
Other Intervention Name(s)
Anafranil
Intervention Description
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
Intervention Type
Drug
Intervention Name(s)
Quetiapine (fluoxetine plus quetiapine)
Other Intervention Name(s)
Seroquel
Intervention Description
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo (fluoxetine plus placebo)
Other Intervention Name(s)
Prozac, Daforin (EMS pharmaceutics)
Intervention Description
Placebo plus fluoxetine at maximum dosage of 80mg per day
Primary Outcome Measure Information:
Title
YBOCS
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
QoL
Description
Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.
Time Frame
12 weeks
Title
Social Adaptation
Description
Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12
Time Frame
12 weeks
Title
Tolerability
Description
Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome)
Time Frame
weeks 0,1,2,3,4,8,12
Title
BDI
Description
Score obtained with Beck depression inventory (BDI)
Time Frame
12 weeks
Title
BAI
Description
Score obtained with Beck´s anxiety inventory (BAI)
Time Frame
12 weeks
Title
CGI
Description
Clinical global impression measure of improvement
Time Frame
12 weeks
Title
Cardiotoxicity
Description
Change from baseline EKG regarding QT interval
Time Frame
2 weeks
Title
Plasma levels
Description
Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)
Time Frame
weeks 2 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
OCD diagnosis
YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)
Previously signed informed consent to participate in this clinical trial
Exclusion Criteria:
Patients with clinical or neurological diseases that may be worsen by the medications included in treatment protocol
Current substance dependence or abuse
Current psychotic symptoms
Current suicide risk
Current pregnancy or intention to get pregnant before the end of the treatment protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana B Diniz, MD
Organizational Affiliation
University of Sao Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychiatry
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22020357
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.
Results Reference
derived
PubMed Identifier
19578654
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.
Results Reference
derived
Links:
URL
http://www.ipqhc.org.br/
Description
Institutional site of main sponsor
URL
https://www.ncbi.nlm.nih.gov/pubmed/22020357
Description
Main results
URL
https://www.ncbi.nlm.nih.gov/pubmed/24288238
Description
Secondary analysis results
Learn more about this trial
Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment
We'll reach out to this number within 24 hrs