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

Primary Purpose

Obsessive Compulsive Disorder (OCD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RG1068 (Synthetic Human Secretin)
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Obsessive Compulsive Disorder (OCD) focused on measuring Obsessive Compulsive Disorder, RG 1068 (Synthetic Human Secretin)

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • LaRue Carter Hospital

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
July 14, 2006
Sponsor
Indiana University School of Medicine
Collaborators
Shekhar, Anantha M.D., Ph.D., Repligen Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00216294
Brief Title
Safety Study of the Drug RG1068 in Patients With Obsessive Compulsive Disorder
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University School of Medicine
Collaborators
Shekhar, Anantha M.D., Ph.D., Repligen Corporation

4. Oversight

5. Study Description

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), 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder (OCD)
Keywords
Obsessive Compulsive Disorder, RG 1068 (Synthetic Human Secretin)

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
RG1068 (Synthetic Human Secretin)
Primary Outcome Measure Information:
Title
Change in Yale-Brown Obsessive Compulsive Scale and
Title
Clinical Global Impression of Change Scale
Secondary Outcome Measure Information:
Title
Change in Hamilton Anxiety Scale,
Title
Montgomery-Asberg Depressing Rating Scale, and
Title
the Sickness Impact Profile

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anantha Shekhar, MD, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
LaRue Carter Hospital
City
Indianapolis,
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States

12. IPD Sharing Statement

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

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