POC Study of Pipamperone Added to Stable Treatment With RIS or PAL in Chronic Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450514
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
PharmaNeuroBoost N.V.

Brief 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 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.

Condition or disease Intervention/treatment Phase
Chronic Schizophrenia Schizoaffective Disorder Drug: Pipamperone Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Sugar pill
Drug: Placebo
matching placebo sugar pill once daily per os on top of continued stable treatment with RIS or PAL
Experimental: Pipamperone
15 mg once daily
Drug: Pipamperone
15 mg PIP once daily per os on top of continued stable treatment with RIS or PAL
Other Name: Risperdal, Invega and Xeplion

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Change from baseline in residual PANSS item(s) [ Time Frame: 2 weeks and 6 weeks after study treatment start ]
    PANSS = Positive and Negative Syndrome Scale

  2. Change from baseline in SWN score and subitem scores [ Time Frame: 2 weeks and 6 weeks after study treatment start ]
    SWN = Subjective Well-being under Neuroleptics questionnaire

  3. Change from baseline in IMI-SR score and subitem scores [ Time Frame: 2 weeks and 6 weeks after study treatment start ]
    IMI-SR = Intrinsic Motivation Inventory for Schizophrenia Research (questionnaire)

  4. CGI-I score [ Time Frame: 2 weeks and 6 weeks after study treatment start ]
    CGI-I = Clinical Global Impression if Improvement

  5. Change from baseline in BARS total and subitem scores [ Time Frame: 6 weeks after study treatment start ]
    BARS = Barnes Akathisia Rating Scale

  6. Change from baseline in BACS score and subitem scores [ Time Frame: 1 day, 2 weeks and 6 weeks after study treatment start ]
    BACS = Brief Assessment of Cognition Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450514

University Psychiatric Institute Sint-Jozef
Kortenberg, Belgium
Sponsors and Collaborators
PharmaNeuroBoost N.V.
Principal Investigator: Marc De Hert, M.D., PhD University Psychiatric Institute Sint-Jozef Leuvensesteenweg 517 B-3070 Kortenberg, Belgium

Responsible Party: PharmaNeuroBoost N.V. Identifier: NCT01450514     History of Changes
Other Study ID Numbers: PNB02-C201
2011-004494-81 ( EudraCT Number )
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs