Phosphodiesterase (PDE) Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia

NCT ID: NCT01813955

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-06-30

Brief 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.

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.

Conditions

Schizophrenia; Cognitive Deficits

Keywords

phosphodiesterase inhibitor; Psychophysiology; Cognition; Schizophrenia; Papaverine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Papaverine or placebo

Intervention Type: DRUG

Papaverine delayed release (depot capsule, 300 mg, orally, one single dosage per subject) or placebo

Interventions

Papaverine or placebo

Papaverine delayed release (depot capsule, 300 mg, orally, one single dosage per subject) or placebo

Intervention Type: DRUG

Other Intervention Names

Papaverine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Birte Glenthoj

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birte Glenthøj, Professor

Role: STUDY_DIRECTOR

University of Copenhagen

Mikkel E Sørensen, PHD student

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Bob Oranje, PHD

Role: STUDY_DIRECTOR

Center for Neuropsychiatric Schizophrenia Research

Locations

Glostrup psychiatric center

Glostrup Municipality, , Denmark

Countries

Denmark

Other Identifiers

Papaverine schizophrenia

Identifier Type: -

Identifier Source: org_study_id