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PDE Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia

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What is being tested

Papaverine or placebo

Drug
Who is being recruted

Mental Disorders+2

+ Neurocognitive Disorders

+ Schizophrenia Spectrum and Other Psychotic Disorders

From 18 to 60 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Early Phase 1
Interventional
Study Start: June 2011
See protocol details

Summary

Principal SponsorUniversity of Copenhagen
Last updated: May 28, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01813955
Principal SponsorUniversity of Copenhagen
Last updated: May 28, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersNeurocognitive DisordersSchizophrenia Spectrum and Other Psychotic DisordersCognition DisordersSchizophrenia

Criteria

5 inclusion criteria required to participate
Diagnosed Schizophrenia (WHO ICD 10)
Mono antipsychotic treatment
No regular Antidepressants (PN accepted)
No regular Benzodiazepines (PN accepted)
Show More Criteria
3 exclusion criteria prevent from participating
Dependence syndrome
MRI incompatible, non removable objects above shoulders
Severe physical illness

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Glostrup psychiatric center

Glostrup Municipality, DenmarkOpen Glostrup psychiatric center in Google Maps
SuspendedOne Study Center