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

Schizophrenia Clinical Trial

Official title:

PDE Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01813955
• Other study ID #: Papaverine schizophrenia
• Status: Terminated
• Phase: Phase 0
• First received: September 19, 2011
• Last updated: May 27, 2015
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: May 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficits
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Denmark	Glostrup psychiatric center	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychophysiology	Prepulse inhibition of the startle reflex, Mismatch negativity, P300 amplitude	1 hour after intake of capsule with papaverine or placebo	No
Secondary	Hemodynamic changes	Changes in Hemodynamics, as observed by MR techniques	1 hour after intake of capsule with papaverine or placebo	No