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

What Was Tested

The trial (phase 2) is built around Secretin.

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.

It had two arms (groups): Currently treated with SSRI (experimental) and Not currently treated with SSRI (experimental).

The registry classes the interventions as drug.

More on the Plan

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 a Selective Serotonin Reuptake Inhibitor (SSRI).

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.

This group will also be divided between those receiving SSRI's and those not receiving SSRI's.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Outpatients with a primary DSM-IV diagnosis of OCD. Age 18-40 years, inclusive. 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. Competent to give informed consent.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: moderate to severe depression (madrs \>25); 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.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Secretin study: the participants and staff both knew the treatment.

It started in 2005-02 with completion listed for 2006-04.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Change in Yale-Brown Obsessive Compulsive Scale and. Clinical Global Impression of Change Scale.

It also tracked 3 secondary outcomes, for example Change in Hamilton Anxiety Scale,, Montgomery-Asberg Depressing Rating Scale, and and the Sickness Impact Profile.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Secretin in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, all human trials.