Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216294
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2005-09-13
Brief Title:
Safety Study of the Drug RG1068 in Patients With Obsessive Compulsive Disorder
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 a Selective Serotonin Reuptake Inhibitor SSRI The first 8 patients enrolled will receive subcutaneous injections of RG1068 at 10 µgkg and will be divided between those receiving SSRIs and those not receiving SSRIs Those not receiving SSRI treatment will further be divided between newly diagnosed SSRI-naïve patients and patients who received SSRIs 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 µgkg This group will also be divided between those receiving SSRIs and those not receiving SSRIs Those not receiving SSRI treatment will be further divided in the same manner as before newly diagnosed SSRI-naïve patients and patients who received SSRIs in the past but who have discontinued treatment for at least twelve weeks prior to enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4587029 | None | None | None |