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| Sponsor: | Indiana University School of Medicine |
|---|---|
| Collaborators: |
Shekhar, Anantha M.D., Ph.D. Repligen Corporation |
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00216294 |
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 II |
| Study Type: | Interventional |
| Study Design: | Educational/Counseling/Training, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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) |
| Estimated Enrollment: | 16 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | April 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| LaRue Carter Hospital | |
| Indianapolis,, Indiana, United States, 46222 | |
| Principal Investigator: | Anantha Shekhar, MD, PhD | Indiana University School of Medicine |
More Information
| Study ID Numbers: | 0407-32, 4587029 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 14, 2006 |
| ClinicalTrials.gov Identifier: | NCT00216294 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Obsessive Compulsive Disorder RG 1068 (Synthetic Human Secretin) |
|
Secretin Pathologic Processes Disease Anxiety Disorders Mental Disorders Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Hormones Pharmacologic Actions Obsessive-Compulsive Disorder |