Proof-of-Concept Study of Pipamperone Added to Stable Treatment With Risperidone or Paliperidone in Chronic Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by PharmaNeuroBoost N.V..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
PharmaNeuroBoost N.V.
ClinicalTrials.gov Identifier:
NCT01450514
First received: October 7, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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. This exploratory study of 7 weeks will 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.


Condition Intervention Phase
Chronic Schizophrenia
Schizoaffective Disorder
Drug: Pipamperone
Drug: sugar pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proof-of-Concept 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

Resource links provided by NLM:


Further study details as provided by PharmaNeuroBoost N.V.:

Primary Outcome Measures:
  • Change from baseline in functional MRI tests [ Time Frame: 1 day, 2 weeks and 6 weeks after study treatment start ] [ Designated as safety issue: No ]
    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:
  • Change from baseline in residual PANSS item(s) [ Time Frame: 2 weeks and 6 weeks after study treatment start ] [ Designated as safety issue: No ]
    PANSS = Positive and Negative Syndrome Scale

  • Change from baseline in SWN score and subitem scores [ Time Frame: 2 weeks and 6 weeks after study treatment start ] [ Designated as safety issue: No ]
    SWN = Subjective Well-being under Neuroleptics questionnaire

  • Change from baseline in IMI-SR score and subitem scores [ Time Frame: 2 weeks and 6 weeks after study treatment start ] [ Designated as safety issue: No ]
    IMI-SR = Intrinsic Motivation Inventory for Schizophrenia Research (questionnaire)

  • CGI-I score [ Time Frame: 2 weeks and 6 weeks after study treatment start ] [ Designated as safety issue: No ]
    CGI-I = Clinical Global Impression if Improvement

  • Change from baseline in BARS total and subitem scores [ Time Frame: 6 weeks after study treatment start ] [ Designated as safety issue: Yes ]
    BARS = Barnes Akathisia Rating Scale

  • Change from baseline in BACS score and subitem scores [ Time Frame: 1 day, 2 weeks and 6 weeks after study treatment start ] [ Designated as safety issue: No ]
    BACS = Brief Assessment of Cognition Scale


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sugar pil Drug: sugar pill
15 mg matching placebo once daily per os on top of continued stable treatment with RIS or PAL
Experimental: Pipamperone 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450514

Contacts
Contact: Philippe Lemmens, PhD +32 11 48 07 54 philippe.lemmens@pharmaneuroboost.com

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

No publications provided

Responsible Party: PharmaNeuroBoost N.V.
ClinicalTrials.gov Identifier: NCT01450514     History of Changes
Other Study ID Numbers: PNB02-C201, 2011-004494-81
Study First Received: October 7, 2011
Last Updated: June 6, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pipamperone
Risperidone
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 22, 2014