Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00743834
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 years, with OCD of at least 1 year's duration, meeting DSM-IV diagnostic criteria, and having a baseline Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of 18.
Exclusion Criteria:
* Pregnant or nursing women or women of childbearing age not using an effective contraceptive method
* Organic mental disorder
* Bipolar disorder
* Psychotic disorder
* History of substance abuse or dependence within 3 years of evaluation for study
* Major depression with suicidal risk
* Major depression dominating the clinical picture
* Panic disorder
* Personality disorder severe enough to interfere with cooperation with study procedures
* Need for antipsychotic medication
* Depot neuroleptic drug within 6 months
* Fluoxetine within 5 weeks
* An MAOI within 2 weeks, any nightly sedative, or taking a medication that may interact with fluvoxamine
* Serious or unstable medical condition (hematological, endocrine, cardiovascular, renal or gastrointestinal), a history of malignancy (other than excised basal cell carcinoma), history of brain disease, including more than one childhood febrile convulsion and all forms of epilepsy; or, are receiving behavior therapy for OCD.
* Subjects who qualify for the study while taking an SSRI must have been taking their current dose or a higher dose for at least 12 weeks prior to study baseline.
* Subjects who qualify for the study while taking fluvoxamine must be taking no more than 150 mg/day and never had a trial at a higher dose, must be believed by the investigator to be able to tolerate an increase to 250 mg/day starting at baseline, and must have been taking their pre-study dose or a higher dose (up to 150 mg/day) for at least 12 weeks prior to study baseline.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00743834
Study Brief:
Protocol Section:
NCT00743834