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

Condition(s) targeted: Obsessive Compulsive Disorder (OCD)

Intervention: RG1068 (Synthetic Human Secretin) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
Anantha Shekhar, MD, PhD, Principal Investigator, Affiliation: Indiana University School of Medicine

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.

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 design: Educational/Counseling/Training, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Change in Yale-Brown Obsessive Compulsive Scale and

Clinical Global Impression of Change Scale

Secondary outcome:

Change in Hamilton Anxiety Scale,

Montgomery-Asberg Depressing Rating Scale, and

the Sickness Impact Profile

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.

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

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.

LaRue Carter Hospital, Indianapolis,, Indiana 46222, United States

Starting date: February 2005
Ending date: April 2006
Last updated: July 14, 2006