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:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT00758966
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects, 18 to 60 years of age (inclusive)
* Outpatients with a current diagnosis of OCD that have received previous therapy
* Negative serum pregnancy test as screening in women of child-bearing potential
* If a woman of child-bearing potential, must agreed to use an acceptable and effective form of contraception
* No clinically significant abnormality on electrocardiogram (ECG)
* No clinically significant laboratory abnormality at screening
* Negative urine drug screen
* Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule
Exclusion Criteria:
* Diagnosis of substance dependence
* Diagnosis of substance abuse (except for nicotine and caffeine)
* Serious or unstable medical illnesses
* Lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, anorexia nervosa, Pervasive Developmental Disorder (PDD), Asperger's Syndrome or the presence of antisocial or borderline personality disorder
* Diagnosis of tic disorder or Tourette's Syndrome
* Subjects diagnosed with impulse control disorder
* Known sensitivity or allergic reaction to either naltrexone or fluoxetine
* Any condition which in the opinion of the investigator or Sponsor makes the subject unsuitable for inclusion in the study
* Immediate family of investigators, study personnel or Sponsor representatives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00758966
Study Brief:
Protocol Section:
NCT00758966