- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01813955
Phosphodiesterase (PDE) Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia
PDE Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia
Phosphodiesterase (PDE) inhibitors represent a new group of potential antipsychotic compounds currently under development. One of these is papaverine, an inhibitor of the PDE 10 family. The class of PDE10 inhibitors have been reported as possible candidates in the treatment of schizophrenia, and may prove an attractive antipsychotic alternative due to the many side-effects of the currently available antipsychotics. It has been proposed from preclinical studies that PDE10 inhibitors have the potential to reduce cognitive deficits in schizophrenia and these findings need to be confirmed in a human population, in view of the fact that no other currently registered drug posses these unique properties.
The currently proposed project is designed to investigate whether the PDE10 inhibitor Papaverine indeed have the capacity to reduce cognitive deficits in schizophrenia patients. In order to accomplish this effect, Papaverine will be investigated in schizophrenia, with regards to symptomatology, hemodynamic, neurocognition and early information-processing.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Glostrup, Denmark, 2600
- Glostrup psychiatric center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed Schizophrenia (WHO ICD 10)
- Treatment stable (no regulation in medicine for 6 weeks prior)
- Mono antipsychotic treatment
- No regular Antidepressants (PN accepted)
- No regular Benzodiazepines (PN accepted)
Exclusion Criteria:
- Dependence syndrome
- Severe physical illness
- MRI incompatible, non removable objects above shoulders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Papaverine
Patients will receive either Papaverine or placebo added to their current medical treatment.
Then after one week, they will receive the other treatment (if it was placebo first, then it will be papaverine; if it was papaverine first, then it will be placebo)
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Papaverine delayed release (depot capsule, 300 mg, orally, one single dosage per subject) or placebo
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychophysiology
Time Frame: 1 hour after intake of capsule with papaverine or placebo
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Prepulse inhibition of the startle reflex, Mismatch negativity, P300 amplitude
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1 hour after intake of capsule with papaverine or placebo
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemodynamic changes
Time Frame: 1 hour after intake of capsule with papaverine or placebo
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Changes in Hemodynamics, as observed by MR techniques
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1 hour after intake of capsule with papaverine or placebo
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Birte Glenthøj, Professor, University of Copenhagen
- Principal Investigator: Mikkel E Sørensen, PHD student, University of Copenhagen
- Study Director: Bob Oranje, PHD, Center for Neuropsychiatric Schizophrenia Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Papaverine schizophrenia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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