Phosphodiesterase (PDE) Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia
Information source: University of Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Cognitive Deficits
Intervention: Papaverine or placebo (Drug)
Phase: Phase 0
Status: Terminated
Sponsored by: University of Copenhagen Official(s) and/or principal investigator(s):
Birte Glenthøj, Professor, Study Director, Affiliation: University of Copenhagen
Mikkel E Sørensen, PHD student, Principal Investigator, Affiliation: University of Copenhagen
Bob Oranje, PHD, Study Director, Affiliation: Center for Neuropsychiatric Schizophrenia Research
Summary
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.
Clinical Details
Official title: PDE Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia
Study design: Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Primary outcome: psychophysiology
Secondary outcome: Hemodynamic changes
Detailed description:
The study has a double blind, balanced crossover design. Randomized, half of the subjects
will be given Papaverine (PDE10 inhibitor, 300 mg orally) in the first session followed by
placebo in the second, and the other half will be treated in the reverse order. There is a
minimum of one month between the two test-sessions. After each of the two treatments, the
subjects will be tested with both a psychophysiological (the Copenhagen Psychophysiological
Test-Battery) and neuropsychological test-battery (tests from the Cambridge
Neuropsychological Test Automated Battery, or "CANTAB"). The project has three phases: In
the first phase 10 healthy subjects will be included to determine the kinetics of
Papaverine-contained release capsules ; in the second phase 30 schizophrenia patients and 30
healthy subjects will be included to determine the impact on cognitive and sensory gating
related deficits; Finally 10 Healthy subjects will be included to determine the effect of
Papaverine on hemodynamical parameters by the means magnetic resonance scannings.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Glostrup psychiatric center, Glostrup 2600, Denmark
Additional Information
Starting date: June 2011
Last updated: May 27, 2015
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