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

NCT00216294 | Completed Phase 2

• 2 other identifiers: 0407-324587029
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 OCD patients' anxiety, quality of life, and depression.

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

Obsessive Compulsive Disorder; RG 1068 (Synthetic Human Secretin)

Outcome Measures

Primary Outcomes (2)

• Change in Yale-Brown Obsessive Compulsive Scale and

• Clinical Global Impression of Change Scale

Secondary Outcomes (3)

• Change in Hamilton Anxiety Scale,

• Montgomery-Asberg Depressing Rating Scale, and

• the Sickness Impact Profile

Study Arms (2)

Currently treated with SSRI

EXPERIMENTAL

Drug: RG1068 (Synthetic Human Secretin)

Not currently treated with SSRI

EXPERIMENTAL

Drug: RG1068 (Synthetic Human Secretin)

Interventions

RG1068 (Synthetic Human Secretin) DRUG

Currently treated with SSRI; Not currently treated with SSRI

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Shekhar, Anantha M.D., Ph.D.: collaborator
• Repligen Corporation: collaborator

Study Sites (1)

LaRue Carter Hospital

Indianapolis, Indiana, 46222, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Secretin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Anantha Shekhar, MD, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

US (1)