NCT01813955

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for early_phase_1 schizophrenia

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

September 19, 2011

Last Update Submit

May 27, 2015

Conditions

SchizophreniaCognitive Deficits

Keywords

phosphodiesterase inhibitorPsychophysiologyCognitionSchizophreniaPapaverine

Outcome Measures

Primary Outcomes (1)

  • psychophysiology

    Prepulse inhibition of the startle reflex, Mismatch negativity, P300 amplitude

    1 hour after intake of capsule with papaverine or placebo

Secondary Outcomes (1)

  • Hemodynamic changes

    1 hour after intake of capsule with papaverine or placebo

Study Arms (1)

Papaverine

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)

Drug: Papaverine or placebo

Interventions

Papaverine or placeboDRUG

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

Also known as: Papaverine
Papaverine

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Dependence syndrome
  • Severe physical illness
  • MRI incompatible, non removable objects above shoulders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup psychiatric center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

SchizophreniaCognition Disorders

Interventions

Papaverine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

BenzylisoquinolinesAlkaloidsHeterocyclic CompoundsOpiate AlkaloidsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Birte Glenthøj, Professor

    University of Copenhagen

    STUDY DIRECTOR

  • Mikkel E Sørensen, PHD student

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Bob Oranje, PHD

    Center for Neuropsychiatric Schizophrenia Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 19, 2011

First Posted

March 19, 2013

Study Start

June 1, 2011

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

DK(1)