Treatment of Obsessive-Compulsive Disorder

NCT00000373 | Completed Phase 4

• 1 other identifier: R01MH045802
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

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

Obsessive-Compulsive Disorder

Keywords

Adolescence; Adult; Antipsychotic Agents; Dopamine Antagonists; Female; Fluvoxamine; Haloperidol; Human; Male; Middle Age; Obsessive-Compulsive Disorder; Placebos; Serotonin Uptake Inhibitors; Tourette Syndrome; Tryptophan; Drug Combinations; Antipsychotic Agents -- *therapeutic use; Fluvoxamine -- *therapeutic use; Haloperidol -- *therapeutic use; Obsessive-Compulsive Disorder -- *drug therapy; Obsessive-Compulsive Disorder -- physiopathology; Serotonin Uptake Inhibitors -- *therapeutic use

Outcome Measures

Primary Outcomes (1)

• 25% reduction in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score from baseline

  Baseline, Week s 1, 2, 4, 6, 8, 10, 12, and 14

Study Arms (2)

olanzapine + fluoxetine

ACTIVE COMPARATOR

The specific aim was to determine whether combined treatment with fluoxetine plus olanzapine would be more effective than fluoxetine plus placebo in treating OCD subjects who were partial or nonresponders to a prospective, 8-week, open-label trial of fluoxetine.

Drug: placebo + fluoxetine

placebo + fluoxetine

PLACEBO COMPARATOR

The specific aim was to determine whether combined treatment with fluoxetine plus olanzapine would be more effective than fluoxetine plus placebo in treating OCD subjects who were partial or nonresponders to a prospective, 8-week, open-label trial of fluoxetine.

Drug: olanzapine + fluoxetine

Interventions

olanzapine + fluoxetine DRUG

placebo + fluoxetine

placebo + fluoxetine DRUG

olanzapine + fluoxetine

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Psychiatric Specialty Clinic, Shands Hospital at the University of Florida

Gainesville, Florida, 32608, United States

Location

University of Florida Behavioral Health Mandarin Clinic

Jacksonville, Florida, 32257, United States

Location

Related Publications (2)

• Shapira NA, Ward HE, Mandoki M, Murphy TK, Yang MC, Blier P, Goodman WK. A double-blind, placebo-controlled trial of olanzapine addition in fluoxetine-refractory obsessive-compulsive disorder. Biol Psychiatry. 2004 Mar 1;55(5):553-5. doi: 10.1016/j.biopsych.2003.11.010.

  PMID: 15023585 BACKGROUND

• Koran LM, Bromberg D, Hornfeldt CS, Shepski JC, Wang S, Hollander E. Extended-release fluvoxamine and improvements in quality of life in patients with obsessive-compulsive disorder. Compr Psychiatry. 2010 Jul-Aug;51(4):373-9. doi: 10.1016/j.comppsych.2009.10.001. Epub 2009 Dec 21.

  PMID: 20579510 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Tourette Syndrome

Interventions

olanzapine-fluoxetine combination; Fluoxetine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Wayne Goodman, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: September 1, 1992
• Primary Completion: January 1, 2003
• Study Completion: July 1, 2003
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

US (2)