Clinical Trials Logo
  1. Home
  2. Chronic Schizophrenia
  3. NCT01450514

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

Schizoaffective Disorder Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01450514
Study type Interventional
Source PharmaNeuroBoost N.V.
Contact
Status Completed
Phase Phase 2
Start date March 2012
Completion date December 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT01878513 - Prospective Cytochrome P450 Genotyping and Clinical Outcomes in Patients With Psychosis N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Not yet recruiting NCT04551027 - Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness N/A
Terminated NCT02796144 - MEtformin and Lorcaserin for WeighT Loss in Schizophrenia Phase 4
Completed NCT02901587 - Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder Phase 1
Completed NCT02160249 - RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia) N/A
Recruiting NCT02986490 - Magnesium Variations and Cardiometabolic Risk in Patients With Antipsychotic Drugs N/A
Completed NCT02417142 - Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia Phase 4
Terminated NCT02234752 - Galantamine and Memantine Combination for Cognitive Impairments in Schizophrenia Phase 2
Completed NCT02091388 - Bioavailability of LY03004 and Risperdal® Consta® Phase 1
Completed NCT01975584 - Neuroendocrine and Immune Response to Stress in Schizophrenia N/A
Completed NCT01945333 - Personalized and Scalable Cognitive Remediation Approaches N/A
Completed NCT01992393 - Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME) N/A
Terminated NCT02149823 - Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations Phase 1
Completed NCT01658150 - Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder N/A
Completed NCT01683539 - Understanding How Cognitive Remediation Works N/A
Completed NCT01292577 - Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia Phase 1/Phase 2