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

NCT01450514 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-11-19

No results posted yet for this study

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

Interventions

DRUG

Pipamperone

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

DRUG

Placebo

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

Sponsors & Collaborators

  • PharmaNeuroBoost N.V.

    lead INDUSTRY

Principal Investigators

  • Marc De Hert, M.D., PhD · University Psychiatric Institute Sint-Jozef Leuvensesteenweg 517 B-3070 Kortenberg, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450514 on ClinicalTrials.gov