SchizophreniaEarly Phase 1NCT01813955
Phosphodiesterase (PDE) Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia
A Early Phase 1 study of Schizophrenia and Cognitive Deficits, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Cognitive Deficits
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Jun 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Dependence syndrome
- Severe physical illness
- MRI incompatible, non removable objects above shoulders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PDE Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia
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.
Read the 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
- Being tested
- Papaverine or placebo
- Keywords
- phosphodiesterase inhibitor, Psychophysiology, Cognition, Schizophrenia, Papaverine
- Medical subject headings
- Schizophrenia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papaverine or placeboDrug
Also called Papaverine
Papaverine delayed release (depot capsule, 300 mg, orally, one single dosage per subject) or placebo
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Papaverine or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychophysiology
Prepulse inhibition of the startle reflex, Mismatch negativity, P300 amplitude
Measured: 1 hour after intake of capsule with papaverine or placebo
Secondary outcomes (1)
Hemodynamic changes
Changes in Hemodynamics, as observed by MR techniques
Measured: 1 hour after intake of capsule with papaverine or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJun 2011
- Primary completionMay 2013
- Study completionJun 2013
Why it stopped: Patient recruitment insufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Responsible party
- Principal investigator, Birte Glenthoj, University of Copenhagen
- Investigators
- Birte Glenthøj, Professor, Study director, University of CopenhagenMikkel E Sørensen, PHD student, Principal investigator, University of CopenhagenBob Oranje, PHD, Study director, Center for Neuropsychiatric Schizophrenia Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813955
- Sponsor's protocol ID
- Papaverine schizophrenia
- Status last verified
- May 2015
- First submitted
- 19 Sep 2011
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PDE Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia
- ClinicalTrials.gov ID
- NCT01813955
- Acronym / sponsor ID
- Papaverine schizophrenia
- Conditions
- Schizophrenia, Cognitive Deficits
- Keywords
- phosphodiesterase inhibitor, Psychophysiology, Cognition, Schizophrenia, Papaverine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient recruitment insufficient
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Study start
- Jun 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Papaverine | Experimental | Drug: Papaverine or placeboPatients 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Dependence syndrome
- Severe physical illness
- MRI incompatible, non removable objects above shoulders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Papaverine or placeboAlso: PapaverinePapaverine delayed release (depot capsule, 300 mg, orally, one single dosage per subject) or placebo | Drug | Papaverine |
Primary outcome
psychophysiology
Time frame: 1 hour after intake of capsule with papaverine or placebo
Prepulse inhibition of the startle reflex, Mismatch negativity, P300 amplitude
1 secondary outcome
Hemodynamic changes
Time frame: 1 hour after intake of capsule with papaverine or placebo
Results and safety
The study was stopped early (reason given: Patient recruitment insufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birte Glenthøj, Professor study director
University of Copenhagen
Mikkel E Sørensen, PHD student principal investigator
University of Copenhagen
Bob Oranje, PHD study director
Center for Neuropsychiatric Schizophrenia Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Schizophrenia and Cognitive Deficits, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Patient recruitment insufficient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychophysiology (time frame: 1 hour after intake of capsule with papaverine or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.