Chronic SchizophreniaPhase 2NCT01450514
POC Study of Pipamperone Added to Stable Treatment With RIS or PAL in Chronic Schizophrenia
A Phase 2 study testing Pipamperone in people with Chronic Schizophrenia and Schizoaffective Disorder, run by PharmaNeuroBoost N.V. at 1 site in Belgium.
Trial summary
This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and clinical outcome of chronic schizophrenic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Pipamperone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Dec 2012
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- Patient understands the investigational nature of the trial and is willing and able to comply with the trial requirements.
- Patient is male or female, aged 18-65 years.
- Patients has Schizophrenia or Schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-R criteria. Diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Patient is being treated during at least 12 weeks with a stable dosage of either risperidone depot of 12.5-50mg IM every 2 weeks, paliperidone depot of 25-100mg IM every 4 weeks, risperidone oral administration of 2-6 mg/d, or paliperidone oral administration of 4-12 mg/d
- Patient has a CGI-S score of 3 (mildly ill) or more at baseline.
- Patient has a score of 4 or more on at least 1 item of the positive PANSS subscale (residual symptoms).
Who cannot join
- Acute exacerbation of schizophrenic or schizoaffective disorder during the past 12 weeks.
- Documented debility or an IQ below 85.
- Comorbid axis 1 conditions (including anxiety disorders, eating disorders, impulse control disorders) requiring drug treatment over the previous 12 weeks.
- Patient has taken, in the past 6 weeks prior to randomization, any newly initiated psychoactive drug.
- Patient was withdrawn from psychoactive drug treatment in the past week or within a period shorter than 5x the elimination half-life of any psychoactive drug. Withdrawal of any prior antipsychotic treatment should not have occurred within 6 weeks prior to baseline.
- Concomitant treatment with any additional antipsychotic drug at a therapeutic dosage, diuretics, QT prolongation drugs, or dopamine agonists.
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- Formal cognitive psychotherapy initiated during study treatment or within 6 weeks prior to randomization.
- Patient has any other medical or psychiatric condition, which in the opinion of the investigator, can jeopardize or would compromise the patient's ability to participate in this trial or that would interfere with trial assessments.
- Patient with a DSM-IV alcohol or substance dependence diagnosis (within the last 6 months), an alcohol or substance abuse diagnosis (within the last month) or having a positive standard screen for alcohol or drugs (including benzodiazepines and opioids).
- 'Any concomitant psychoactive treatment (including psychotherapy)' or 'Patient received, in the 6 weeks prior to randomization any newly prescribed psychoactive drug'.
- Patient is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or who does not consistently use 2 combined effective methods of contraception (including at least 1 barrier method), unless sexually abstinent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: POC Study of Pipamperone 15mg Added to Stable Risperidone or Paliperidone Treatment in Chronic Schizophrenic and Schizoaffective Patients With Residual Symptoms: a Phase I/IIa, Randomized, Double-blind, Placebo-controlled Trial of 7 Weeks
This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and clinical outcome of chronic schizophrenic patients with residual, so-called 'positive' symptoms, as well as on cognition, motivation, subjective well-being of patients, negative symptoms, general psychopathological symptoms and safety/tolerability.
Read the detailed description
This exploratory study of 7 weeks was intended to be performed in 40 to 60 patients in up to 10 centers in Belgium. In a subset of patients, the 6-week treatment phase will be preceded by a single-dose cross-over phase with 1 week of wash-out. While the objective of the study, due to its exploratory design, is to assess any effect of the study medication on MRI or clinical outcome, the study medication is expected to improve the residual (remaining) positive symptom(s) of patients. In addition, genetic and pharmacokinetic testing may be performed to learn more about the disorder and its treatment.
- Conditions
- Chronic Schizophrenia, Schizoaffective Disorder
- Being tested
- Pipamperone, Placebo
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PipamperoneDrug
Also called Risperdal, Invega and Xeplion
15 mg PIP once daily per os on top of continued stable treatment with RIS or PAL
PlaceboDrug
matching placebo sugar pill once daily per os on top of continued stable treatment with RIS or PAL
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sugar pill Receives: Drug: Placebo |
| Pipamperone | Experimental | 15 mg once daily Receives: Drug: Pipamperone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in functional MRI tests
MRI = Magnetic Resonance Imaging Functional tests performed during MRI include the N-Back Test and the Monetary Incentive Delay (MID) Task Test
Measured: 1 day, 2 weeks and 6 weeks after study treatment start
Secondary outcomes (6)
Change from baseline in residual PANSS item(s)
PANSS = Positive and Negative Syndrome Scale
Measured: 2 weeks and 6 weeks after study treatment start
Change from baseline in SWN score and subitem scores
SWN = Subjective Well-being under Neuroleptics questionnaire
Measured: 2 weeks and 6 weeks after study treatment start
Change from baseline in IMI-SR score and subitem scores
IMI-SR = Intrinsic Motivation Inventory for Schizophrenia Research (questionnaire)
Measured: 2 weeks and 6 weeks after study treatment start
CGI-I score
CGI-I = Clinical Global Impression if Improvement
Measured: 2 weeks and 6 weeks after study treatment start
Change from baseline in BARS total and subitem scores
BARS = Barnes Akathisia Rating Scale
Measured: 6 weeks after study treatment start
Change from baseline in BACS score and subitem scores
BACS = Brief Assessment of Cognition Scale
Measured: 1 day, 2 weeks and 6 weeks after study treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SchizophreniaStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaNeuroBoost N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc De Hert, M.D., PhD, Principal investigator, University Psychiatric Institute Sint-Jozef Leuvensesteenweg 517 B-3070 Kortenberg, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450514
- Sponsor's protocol ID
- PNB02-C201
- Other IDs
- 2011-004494-81
- Status last verified
- Nov 2014
- First submitted
- 7 Oct 2011
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POC Study of Pipamperone 15mg Added to Stable Risperidone or Paliperidone Treatment in Chronic Schizophrenic and Schizoaffective Patients With Residual Symptoms: a Phase I/IIa, Randomized, Double-blind, Placebo-controlled Trial of 7 Weeks
- ClinicalTrials.gov ID
- NCT01450514
- Acronym / sponsor ID
- PNB02-C201
- Conditions
- Chronic Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- PharmaNeuroBoost N.V.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Oct 2011 (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.
This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and clinical outcome of chronic schizophrenic patients with residual, so-called 'positive' symptoms, as well as on cognition, motivation, subjective well-being of patients, negative symptoms, general psychopathological symptoms and safety/tolerability.
Detailed description
This exploratory study of 7 weeks was intended to be performed in 40 to 60 patients in up to 10 centers in Belgium. In a subset of patients, the 6-week treatment phase will be preceded by a single-dose cross-over phase with 1 week of wash-out. While the objective of the study, due to its exploratory design, is to assess any effect of the study medication on MRI or clinical outcome, the study medication is expected to improve the residual (remaining) positive symptom(s) of patients. In addition, genetic and pharmacokinetic testing may be performed to learn more about the disorder and its treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSugar pill |
| Pipamperone | Experimental | Drug: Pipamperone15 mg once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- Patient understands the investigational nature of the trial and is willing and able to comply with the trial requirements.
- Patient is male or female, aged 18-65 years.
- Patients has Schizophrenia or Schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-R criteria. Diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Patient is being treated during at least 12 weeks with a stable dosage of either risperidone depot of 12.5-50mg IM every 2 weeks, paliperidone depot of 25-100mg IM every 4 weeks, risperidone oral administration of 2-6 mg/d, or paliperidone oral administration of 4-12 mg/d
Key exclusion criteria (11 listed)
- Acute exacerbation of schizophrenic or schizoaffective disorder during the past 12 weeks.
- Documented debility or an IQ below 85.
- Comorbid axis 1 conditions (including anxiety disorders, eating disorders, impulse control disorders) requiring drug treatment over the previous 12 weeks.
- Patient has taken, in the past 6 weeks prior to randomization, any newly initiated psychoactive drug.
- Patient was withdrawn from psychoactive drug treatment in the past week or within a period shorter than 5x the elimination half-life of any psychoactive drug. Withdrawal of any prior antipsychotic treatment should not have occurred within 6 weeks prior to baseline.
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 |
|---|---|---|
| PipamperoneAlso: Risperdal, Invega and Xeplion15 mg PIP once daily per os on top of continued stable treatment with RIS or PAL | Drug | Pipamperone |
| Placebomatching placebo sugar pill once daily per os on top of continued stable treatment with RIS or PAL | Drug | Placebo |
Primary outcome
Change from baseline in functional MRI tests
Time frame: 1 day, 2 weeks and 6 weeks after study treatment start
MRI = Magnetic Resonance Imaging Functional tests performed during MRI include the N-Back Test and the Monetary Incentive Delay (MID) Task Test
6 secondary outcomes
Change from baseline in residual PANSS item(s)
Time frame: 2 weeks and 6 weeks after study treatment start
Change from baseline in SWN score and subitem scores
Time frame: 2 weeks and 6 weeks after study treatment start
Change from baseline in IMI-SR score and subitem scores
Time frame: 2 weeks and 6 weeks after study treatment start
CGI-I score
Time frame: 2 weeks and 6 weeks after study treatment start
Change from baseline in BARS total and subitem scores
Time frame: 6 weeks after study treatment start
Change from baseline in BACS score and subitem scores
Time frame: 1 day, 2 weeks and 6 weeks after study treatment start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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Schizophrenia Patients
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.
Marc De Hert, M.D., PhD principal investigator
University Psychiatric Institute Sint-Jozef Leuvensesteenweg 517 B-3070 Kortenberg, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pipamperone in people with Chronic Schizophrenia and Schizoaffective Disorder, run by PharmaNeuroBoost N.V. at 1 site in Belgium.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 19 Nov 2014. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in functional MRI tests (time frame: 1 day, 2 weeks and 6 weeks after study treatment start). 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 19 Nov 2014.