A double-blind, placebo-controlled trial of olanzapine addition in fluoxetine-refractory obsessive-compulsive disorder.
Nathan A Shapira, Herbert E Ward, Miguel Mandoki...
https://pubmed.ncbi.nlm.nih.gov/15023585Completed
Phase 4
Age: 14Years - 70Years
All Genders
ID00000373
Neurobiology/Treatment of Obsessive-Compulsive Disorder
Led by University of Florida · Updated on 2013-11-27
74
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
CONDITIONS
Official Title
Treatment of Obsessive-Compulsive Disorder
Who Can Participate
Age: 14Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion criteria required that subjects, ages 14-70 years, have at least a 1-year duration of a current Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) principal diagnosis of OCD. Furthermore, the OCD had to be defined by a rating of "moderate" or greater on the global severity item of the Clinical Global Impressions (CGI) scale and have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 19 or greater.
Exclusion criteria included primary depression, schizophrenia, or other psychotic disorders; active bipolar disorder; abuse of alcohol or other significant substance within 6 months; increased risk of seizures or history of neurosurgery, encephalitis, or significant head trauma; or a significant medical condition, such as heart, liver, or renal disease. Subjects with an intelligence quotient of less than 80 as determined with the Kaufman Brief Intelligence Test (Kaufman and Kaufman 1990) were excluded.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 2 locations
1
Psychiatric Specialty Clinic, Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32608
Status Unknown
2
University of Florida Behavioral Health Mandarin Clinic
Jacksonville, Florida, United States, 32257
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Extended-release fluvoxamine and improvements in quality of life in patients with obsessive-compulsive disorder.
Lorrin M Koran, Daniel Bromberg, Carl S Hornfeldt...
https://pubmed.ncbi.nlm.nih.gov/20579510