Obsessive Compulsive Disorder (OCD)Phase 2NCT00216294
Safety Study of the Drug RG1068 in Patients With Obsessive Compulsive Disorder
A Phase 2 study testing RG1068 (Synthetic Human Secretin) in people with Obsessive Compulsive Disorder (OCD), run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- RG1068 (Synthetic Human Secretin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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 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.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- RG1068 (Synthetic Human Secretin)
- Keywords
- Obsessive Compulsive Disorder, RG 1068 (Synthetic Human Secretin)
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG1068 (Synthetic Human Secretin)Drug
| Study group | Role | What they receive |
|---|---|---|
| Currently treated with SSRI | Experimental | Not described Receives: Drug: RG1068 (Synthetic Human Secretin) |
| Not currently treated with SSRI | Experimental | Not described Receives: Drug: RG1068 (Synthetic Human Secretin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Shekhar, Anantha M.D., Ph.D., Repligen Corporation
- Investigators
- Anantha Shekhar, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216294
- Sponsor's protocol ID
- 0407-32
- Other IDs
- 4587029
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2005
- Last updated
- 23 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00216294
- Acronym / sponsor ID
- 0407-32
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Obsessive Compulsive Disorder, RG 1068 (Synthetic Human Secretin)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Shekhar, Anantha M.D., Ph.D., Repligen Corporation
- Study start
- Feb 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Currently treated with SSRI | Experimental | Drug: RG1068 (Synthetic Human Secretin) |
| Not currently treated with SSRI | Experimental | Drug: RG1068 (Synthetic Human Secretin) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RG1068 (Synthetic Human Secretin) | Drug | Currently treated with SSRI, Not currently treated with SSRI |
Primary outcome
Change in Yale-Brown Obsessive Compulsive Scale and
Clinical Global Impression of Change Scale
3 secondary outcomes
Change in Hamilton Anxiety Scale,
Montgomery-Asberg Depressing Rating Scale, and
the Sickness Impact Profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anantha Shekhar, MD, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RG1068 (Synthetic Human Secretin) in people with Obsessive Compulsive Disorder (OCD), run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Yale-Brown Obsessive Compulsive Scale and. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.