Safety Study of the Drug RG1068 in Patients With Obsessive Compulsive Disorder

This study has been completed.
Sponsor:
Collaborators:
Shekhar, Anantha M.D., Ph.D.
Repligen Corporation
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00216294
First received: September 13, 2005
Last updated: July 14, 2006
Last verified: April 2006
  Purpose

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), to determine the impact of multiple subcutaneous injections of RG1068 on the symptoms of OCD, as measured by changes in clinical scales, and to evaluate the effect of RG1068 on ODC patients' anxiety, quality of life, and depression.


Condition Intervention Phase
Obsessive Compulsive Disorder (OCD)
Drug: RG1068 (Synthetic Human Secretin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: An Open-Label, Dose Escalation, Pilot Study to Assess the Safety and Efficacy of Subcutaneous RG1068 (Synthetic Human Secretin) in Patients With Obsessive Compulsive Disorder (OCD)

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Change in Yale-Brown Obsessive Compulsive Scale and
  • Clinical Global Impression of Change Scale

Secondary Outcome Measures:
  • Change in Hamilton Anxiety Scale,
  • Montgomery-Asberg Depressing Rating Scale, and
  • the Sickness Impact Profile

Estimated Enrollment: 16
Study Start Date: February 2005
Estimated Study Completion Date: April 2006
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 subjects, will be enrolled in one of two study arms (eight subjects per group), depending on whether or not they are receiving concurrent treatment with an SSRI. The first 8 patients enrolled will receive subcutaneous injections of RG1068 at 10 µg/kg and will be divided between those receiving SSRI’s and those not receiving SSRI’s. Those not receiving SSRI treatment will further be divided between newly diagnosed, SSRI-naïve patients and patients who received SSRI’s in the past but who have discontinued treatment for at least twelve weeks prior to enrollment. If there are no drug-related serious adverse events, an additional eight patients will be enrolled and receive RG1068 at 20 µg/kg. This group will also be divided between those receiving SSRI’s and those not receiving SSRI’s. Those not receiving SSRI treatment will be further divided in the same manner as before; newly diagnosed, SSRI-naïve patients, and patients who received SSRI’s in the past but who have discontinued treatment for at least twelve weeks prior to enrollment.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. outpatients with a primary DSM-IV diagnosis of OCD
  2. age 18-40 years, inclusive
  3. 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)
  4. 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.
  5. 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.
  6. Competent to give informed consent.

Exclusion Criteria:

  1. moderate to severe depression (MADRS >25)
  2. significant risk of suicidal behavior at screening
  3. surgical lesion of anterior capsule (capsulotomy) or cingulate gyrus (cingulotomy)
  4. co-morbid tics, Tourette syndrome, schizo-obsessive disorder, pure obsessive disorder or Axis II disorder
  5. first degree relative with Tourette syndrome
  6. pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS)
  7. current cognitive behavioral psychotherapy
  8. history of sensitivity to any of the ingredients in the study drug
  9. Clinically significant abnormality in any screening laboratory results
  10. 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
  11. 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.
  12. women who are pregnant, breastfeeding, or refuse to use adequate birth control
  13. diagnosis of alcohol or substance abuse and/or dependence in the past 6 months
  14. participating in an investigational drug study within 28 days of Day 1
  15. concomitantly using any psychotropic medication other than SSRI or chloral hydrate for sleep
  16. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216294

Locations
United States, Indiana
LaRue Carter Hospital
Indianapolis,, Indiana, United States, 46222
Sponsors and Collaborators
Indiana University School of Medicine
Shekhar, Anantha M.D., Ph.D.
Repligen Corporation
Investigators
Principal Investigator: Anantha Shekhar, MD, PhD Indiana University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00216294     History of Changes
Other Study ID Numbers: 0407-32, 4587029
Study First Received: September 13, 2005
Last Updated: July 14, 2006
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Indiana University:
Obsessive Compulsive Disorder
RG 1068 (Synthetic Human Secretin)

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Secretin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014