NCT01450514

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: PharmaNeuroBoost N.V. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2011-10-12
• Last updated: 2014-11-19

Locations

1 site across 1 country: Belgium