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

NCT01450514 | Completed Phase 2

• 2 other identifiers: PNB02-C2012011-004494-81
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  1 day, 2 weeks and 6 weeks after study treatment start

Secondary Outcomes (6)

• Change from baseline in residual PANSS item(s)

  2 weeks and 6 weeks after study treatment start

• Change from baseline in SWN score and subitem scores

  2 weeks and 6 weeks after study treatment start

• Change from baseline in IMI-SR score and subitem scores

  2 weeks and 6 weeks after study treatment start

• CGI-I score

  2 weeks and 6 weeks after study treatment start

• Change from baseline in BARS total and subitem scores

  6 weeks after study treatment start

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sugar pill

Drug: Placebo

Pipamperone

EXPERIMENTAL

15 mg once daily

Drug: Pipamperone

Interventions

Pipamperone DRUG

15 mg PIP once daily per os on top of continued stable treatment with RIS or PAL

Also known as: Risperdal, Invega and Xeplion

Pipamperone

Placebo DRUG

matching placebo sugar pill once daily per os on top of continued stable treatment with RIS or PAL

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaNeuroBoost N.V.: lead

Study Sites (1)

University Psychiatric Institute Sint-Jozef

Kortenberg, Belgium

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

pipamperone; Risperidone; Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoxazoles; Azoles

Study Officials

• Marc De Hert, M.D., PhD

  University Psychiatric Institute Sint-Jozef Leuvensesteenweg 517 B-3070 Kortenberg, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

BE (1)