SchizophreniaPhase 2NCT00235274
Effects of RG1068 (Secretin) on Information Processing in Schizophrenia
A Phase 2 study testing Subcutaneous Secretin in people with Schizophrenia, run by Indiana University at 1 site in United States.
Trial summary
The overarching purpose of the proposed study is to determine Secretin's (RG1068) psychophysiological effects on measures of motor learning, affective, and inhibitory information processing in individuals with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Subcutaneous Secretin
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to give informed consent
- DSM-IV diagnosis of schizophrenia
- 18-55 years of age
- Stable medication > 4 weeks
Who cannot join
- Active suicidal ideation
- Concurrent DSM-IV comorbidity with any substance dependence
- A urine drug screen that is qualitatively positive for controlled substances
- Abnormal hepatic function (AST or ALT > 2.5 X the upper limit of normal, or bilirubin > 1.5 X the upper limit of normal)
- Abnormal renal function (BUN or creatinine > 1.5 X the upper limit of normal)
- Abnormal bone marrow function (WBC < 4 x 103/mm3, Platelets <100 x 103/mm3 and hemoglobin <10 g/dl)
Show all 9Show fewer
- Any history of sensitivity to any of the ingredients in the study drug
- Clinically significant organic disease 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.
- Women who are pregnant, breastfeeding, or refuse to use adequate birth control
Trial locations and contacts
1 site in 1 country.
About this study
The overarching purpose of the proposed study is to determine Secretin's (RG1068) psychophysiological effects on measures of motor learning, affective, and inhibitory information processing in individuals with schizophrenia. Motor learning will be assessed with a classical eye-blink conditioning procedure, requiring the learning of a reflexive eye-blink response to a weak puff of air to the eye.
Read the detailed description
In a recent placebo-controlled, double-blind, multicenter study of Secretin in refractory schizophrenics, we found that a patient who received Secretin (1.0 g/kg) intravenously, showed a marked improvement in eye blink conditioning following infusion. This subject also showed a clinical improvement of > 20% on the Total Score and Total Negative Score of the Positive and Negative Syndrome Scale (PANSS). Therefore, the primary objective of this study is to confirm and extend this observation in a larger group of individuals with schizophrenia. In this 24 to 48 hour experiment, the acquisition and extinction of the conditioned blink response will be assessed in participants with schizophrenia who are randomly assigned to one of two double blind treatment groups: (1) subcutaneous saline or (2) subcutaneous Secretin (20 ug/kg). Enrolled participants will remain on their stable medication regime (i.e., psychotropic medications and related treatments will not be manipulated). Furthermore, given evidence that Secretin administration increases the amygdala's activation during experimental presentation of fear-related facial cue stimuli, we wish to also investigate the effects of the experimental agent on psychophysiological processes putatively related to amygdala function. Prepulse inhibition is a widely studied paradigm in the schizophrenia literature, thought to reflect disruption of early sensory-motor gating that is present in both individuals with schizophrenia and their unaffected biological relatives, and can be mediated by various limbic structures including the amygdala. Therefore, as a secondary aim, the effects of Secretin will be tested on affect modulation, pre-pulse inhibition, and pre-pulse facilitation of the acoustic startle response using common psychophysiological research procedures. These procedures are frequently used in our laboratory and are currently approved for our use by the IRBs at both IUPUI and IUB.
- Conditions
- Schizophrenia
- Being tested
- Subcutaneous Secretin
- Keywords
- Schizophrenia, Secretin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous SecretinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor learning will be assessed with a classical eye-blink conditioning procedure, requiring the learning of a reflexive eye-blink response to a weak puff of air to the eye.
Secondary outcomes (1)
Effects of Secretin will be tested on affect modulation, pre-pulse inhibition, and pre-pulse facilitation of the acoustic startle response using common psychophysiological research procedures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startNov 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
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
- NCT00235274
- Sponsor's protocol ID
- 0507-30
- Other IDs
- 4587049
- Status last verified
- Mar 2017
- First submitted
- 6 Oct 2005
- Last updated
- 3 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of RG1068 (Secretin) on Information Processing in Schizophrenia
- ClinicalTrials.gov ID
- NCT00235274
- Acronym / sponsor ID
- 0507-30
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Secretin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Shekhar, Anantha M.D., Ph.D., Repligen Corporation
- Study start
- Nov 2005
- Study completion
- Aug 2006
- First posted
- 10 Oct 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 overarching purpose of the proposed study is to determine Secretin's (RG1068) psychophysiological effects on measures of motor learning, affective, and inhibitory information processing in individuals with schizophrenia. Motor learning will be assessed with a classical eye-blink conditioning procedure, requiring the learning of a reflexive eye-blink response to a weak puff of air to the eye.
Detailed description
In a recent placebo-controlled, double-blind, multicenter study of Secretin in refractory schizophrenics, we found that a patient who received Secretin (1.0 g/kg) intravenously, showed a marked improvement in eye blink conditioning following infusion. This subject also showed a clinical improvement of > 20% on the Total Score and Total Negative Score of the Positive and Negative Syndrome Scale (PANSS). Therefore, the primary objective of this study is to confirm and extend this observation in a larger group of individuals with schizophrenia. In this 24 to 48 hour experiment, the acquisition and extinction of the conditioned blink response will be assessed in participants with schizophrenia who are randomly assigned to one of two double blind treatment groups: (1) subcutaneous saline or (2) subcutaneous Secretin (20 ug/kg). Enrolled participants will remain on their stable medication regime (i.e., psychotropic medications and related treatments will not be manipulated). Furthermore, given evidence that Secretin administration increases the amygdala's activation during experimental presentation of fear-related facial cue stimuli, we wish to also investigate the effects of the experimental agent on psychophysiological processes putatively related to amygdala function. Prepulse inhibition is a widely studied paradigm in the schizophrenia literature, thought to reflect disruption of early sensory-motor gating that is present in both individuals with schizophrenia and their unaffected biological relatives, and can be mediated by various limbic structures including the amygdala. Therefore, as a secondary aim, the effects of Secretin will be tested on affect modulation, pre-pulse inhibition, and pre-pulse facilitation of the acoustic startle response using common psychophysiological research procedures. These procedures are frequently used in our laboratory and are currently approved for our use by the IRBs at both IUPUI and IUB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able to give informed consent
- DSM-IV diagnosis of schizophrenia
- 18-55 years of age
- Stable medication > 4 weeks
Key exclusion criteria (9 listed)
- Active suicidal ideation
- Concurrent DSM-IV comorbidity with any substance dependence
- A urine drug screen that is qualitatively positive for controlled substances
- Abnormal hepatic function (AST or ALT > 2.5 X the upper limit of normal, or bilirubin > 1.5 X the upper limit of normal)
- Abnormal renal function (BUN or creatinine > 1.5 X the upper limit of normal)
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 |
|---|---|---|
| Subcutaneous Secretin | Drug | – |
Primary outcome
Motor learning will be assessed with a classical eye-blink conditioning procedure, requiring the learning of a reflexive eye-blink response to a weak puff of air to the eye.
1 secondary outcome
Effects of Secretin will be tested on affect modulation, pre-pulse inhibition, and pre-pulse facilitation of the acoustic startle response using common psychophysiological research procedures.
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 3 Mar 2017.
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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 Subcutaneous Secretin in people with Schizophrenia, 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 4 inclusion and 9 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 3 Mar 2017. 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?
Motor learning will be assessed with a classical eye-blink conditioning procedure, requiring the learning of a reflexive eye-blink response to a weak puff of air to the eye.. 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 3 Mar 2017.