Status:
COMPLETED
Safety Study of the Drug RG1068 in Patients With Obsessive Compulsive Disorder
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Shekhar, Anantha M.D., Ph.D.
Repligen Corporation
Conditions:
Obsessive Compulsive Disorder (OCD)
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and tolerability of RG1068 (Synthetic Human Secretin) when administered three times weekly to outpatients with obsessive compulsive disorder (OCD),...
Detailed Description
This is an open-label, dose-escalation pilot study. Prospective participants will initially undergo a blinded placebo challenge to assess his or her ability to self-administer drug. A total of sixteen...
Eligibility Criteria
Inclusion
- outpatients with a primary DSM-IV diagnosis of OCD
- age 18-40 years, inclusive
- moderate to severe symptoms of OCD: a) YBOCS score of ≥24; b) CGI-Severity ≥4; c) significant disruption of daily activities (≥2 on item 1 or 6 of the YBOCS); d) disruption of employment/education function (≥2 on item 2 or 7 of the YBOCS)
- if not on SSRI, must: a) have discontinued treatment with an SSRI at least 12 weeks prior to study Day 1; b) or be treatment naïve.
- if on SSRI: a) must have residual symptoms despite a three month trial of an adequate dose of an SSRI drug; b) must currently be on an SSRI for at least 16 weeks and on a stable regimen for at least 8 weeks prior to Day 1.
- Competent to give informed consent.
Exclusion
- moderate to severe depression (MADRS \>25)
- significant risk of suicidal behavior at screening
- surgical lesion of anterior capsule (capsulotomy) or cingulate gyrus (cingulotomy)
- co-morbid tics, Tourette syndrome, schizo-obsessive disorder, pure obsessive disorder or Axis II disorder
- first degree relative with Tourette syndrome
- pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS)
- current cognitive behavioral psychotherapy
- history of sensitivity to any of the ingredients in the study drug
- Clinically significant abnormality in any screening laboratory results
- Clinically significant organic disease (other than OCD), including cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the Investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
- a current, active or ongoing DSM-IV Axis I psychiatric disorder other than anxiety disorders, major depression, dysthymia, and depression not otherwise specified (but including organic mental syndromes or disorders and dementia) as long as these are secondary diagnoses.
- women who are pregnant, breastfeeding, or refuse to use adequate birth control
- diagnosis of alcohol or substance abuse and/or dependence in the past 6 months
- participating in an investigational drug study within 28 days of Day 1
- concomitantly using any psychotropic medication other than SSRI or chloral hydrate for sleep
- receiving treatment with a monoamine oxidase inhibitor within 2 weeks, a depot neuroleptic within 6 months, or a neuroleptic, anxiolytic, or antidepressant on a daily basis in the 2 weeks prior to Day 1.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00216294
Start Date
February 1 2005
End Date
April 1 2006
Last Update
February 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LaRue Carter Hospital
Indianapolis, Indiana, United States, 46222