Clozapine/Paliperidone Versus Clozapine/Placebo in Resistant Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Universidad Nacional de Rosario
ClinicalTrials.gov Identifier:
NCT01279213
First received: January 11, 2011
Last updated: January 18, 2011
Last verified: July 2009
  Purpose

augmentation of clozapine with paliperidone in the treatment of resistant schizophrenia has not been tested until now in randomized controlled trials. This combination is supposed to have therapeutic efficacy in the treatment of resistant schizophrenia.


Condition Intervention Phase
Schizophrenia
Schizophrenic Disorders
Psychotic Disorder
Drug: paliperidone clozapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmentation of Clozapine With Paliperidone in the Treatment of Resistant Schizophrenia Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Universidad Nacional de Rosario:

Primary Outcome Measures:
  • bprs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    improvement in scores total BPRS


Secondary Outcome Measures:
  • cgs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    improvement in CGS


Enrollment: 70
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: paliperidone clozapine BPRS
patients assigned to clozapine plus paliperidone controls at 6 and 12 weeks
Drug: paliperidone clozapine
dose 3 to 12 mg paliperidone ER daily during 12 weeks
Placebo Comparator: clozapine plus placebo BPRS
patients assigned to placebo plus clozapine should show less improvement
Drug: paliperidone clozapine
dose 3 to 12 mg paliperidone ER daily during 12 weeks

Detailed Description:

This is a 12 weeks, blind study (the patient, investigator, and sponsor do not know the study drug and dosage being taken by the patient) of the safety and tolerability of flexible-dose (3 to 12mg per day), extended-release (ER) paliperidone in combination with clozapine with a diagnosis of schizophrenia. Patients who have completed study or who discontinued from that study because of lack of efficacy but completed a minimum of 21 days of the study may enter this study. This study consists of a 21-day screening and washout phase (to discontinue and "wash out" any medication not allowed in the study), and a double blind treatment phase of 12 weeks, during which all patients will take oral paliperidone ER every day and clozapine versus clozapine alone, and a post-treatment phase consisting of a follow-up visit completed 1 week after a patient has received the final dose of paliperidone ER. The study, including the screening and posttreatment phase, will last approximately 30 weeks. Screening and washout may be conducted while a patient is an outpatient. Safety will be assessed by laboratory measurements (chemistry, liver function tests, hematology, hormone, lipid assessments, prolactin [blinded], urinalysis, and urine drug screens; body weight, height, and waist circumference measurements; ECGs and the ESRS (extrapyramidal syndrome rating scale). These instruments will be used to assess extrapyramidal symptoms (EPS) and dyskinesias. Adverse events will be monitored including psychiatric adverse events of interest (worsening of psychosis, hyperprolactinemia, weight gain) that may be associated with paliperidone ER in this population. The primary aim of this study is to evaluate the long-term (12 weeks) safety and tolerability of clozapine/paliperidone ER in resistant schizophrenia. As exploratory secondary aims, the study will assess the effect of clozapine/paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores, the global improvement in severity of illness as measured by the Clinical Global Impression(CGI) scale. Patients begin the study at 6.0 mg/day of oral paliperidone ER. If a higher dosage is needed, the dosage will be increased (in increments of 3 mg/day not more frequently than once every 5 days) to 12 mg/day. If the 6.0 mg/day dosage is not well tolerated, the dosage may be decreased (not more frequently than once every 5 days) to 3.0 mg/day. Patients will be dosed for up to 6 months.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

resistant schizophrenia failure in therapeutic response to three previous antipsychotic drugs -

Exclusion Criteria:

age upper 50 other psychiatric diagnosis head trauma neurological diseases -

  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: NCT01279213

Locations
Argentina
Faculty of Psychology
Rosario, Santa Fe, Argentina, 2000
Sponsors and Collaborators
Universidad Nacional de Rosario
Investigators
Principal Investigator: daniel j serrani azcurra, MD faculty of psychology
  More Information

Publications:
Responsible Party: DANIEL SERRANI, faculty of psychology UNR
ClinicalTrials.gov Identifier: NCT01279213     History of Changes
Other Study ID Numbers: 109
Study First Received: January 11, 2011
Last Updated: January 18, 2011
Health Authority: Argentina: Human Research Bioethics Committee

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

ClinicalTrials.gov processed this record on October 22, 2014