Working... Menu

Clozapine/Paliperidone Versus Clozapine/Placebo in Resistant Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01279213
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : January 19, 2011
Information provided by:
Universidad Nacional de Rosario

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Schizophrenic Disorders Psychotic Disorder Drug: paliperidone clozapine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmentation of Clozapine With Paliperidone in the Treatment of Resistant Schizophrenia Randomized Controlled Study
Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. bprs [ Time Frame: 12 weeks ]
    improvement in scores total BPRS

Secondary Outcome Measures :
  1. cgs [ Time Frame: 12 weeks ]
    improvement in CGS

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01279213

Layout table for location information
Faculty of Psychology
Rosario, Santa Fe, Argentina, 2000
Sponsors and Collaborators
Universidad Nacional de Rosario
Layout table for investigator information
Principal Investigator: daniel j serrani azcurra, MD faculty of psychology

Layout table for additonal information
Responsible Party: DANIEL SERRANI, faculty of psychology UNR Identifier: NCT01279213     History of Changes
Other Study ID Numbers: 109
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: July 2009

Additional relevant MeSH terms:
Layout table for MeSH terms
Paliperidone Palmitate
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
GABA Antagonists
GABA Agents