Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.

Study Overview

• Status: Withdrawn
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: paliperidone palmitate; Drug: olanzapine; Drug: paliperidone; Drug: aripiprazole; Drug: haloperidole; Drug: perphenazine; Drug: quetiapine; Drug: risperidone

Detailed Description

The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)
• Must be an outpatient who, following an acute exacerbation of schizophrenia, has been discharged from an inpatient psychiatric hospital within 60 days of screening
• Have a current diagnosis of schizophrenia
• Have available a designated individual who is likely to have knowledge of the subject's health status and who agrees to let the study site personnel know of changes in the patient's circumstances
• Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control

Exclusion Criteria:

• Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone
• Actively abusing intravenous drugs
• Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
• have an unstable medical illness
• Women who are pregnant or breast-feeding, or planning to become pregnant
• Have received injectable antipsychotic treatment within 2 injection cycles prior to screening
• Received treatment with clozapine within 3 months of screening
• Attempted suicide within 6 months before screening or are at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at time of screening
• homeless at time of stuyd consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months	Drug: paliperidone palmitate; 78, 117, 156, or 234 mg monthly injection for 12 months
Active Comparator: 002; olanzapine flexible dosing as prescribed by the study doctor for 12 months	Drug: olanzapine; flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 003; paliperidone flexible dosing as prescribed by the study doctor for 12 months	Drug: paliperidone; flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 004; aripiprazole flexible dosing as prescribed by the study doctor for 12 months	Drug: aripiprazole; flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 005; haloperidole flexible dosing as prescribed by the study doctor for 12 months	Drug: haloperidole; flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 006; perphenazine flexible dosing as prescribed by the study doctor for 12 months	Drug: perphenazine; flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 007; quetiapine flexible dosing as prescribed by the study doctor for 12 months	Drug: quetiapine; flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 008; risperidone flexible dosing as prescribed by the study doctor for 12 months	Drug: risperidone; flexible dosing as prescribed by the study doctor for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Clinical Global Impression-Severity score	Up to 12 months
Change in Global Assessment of Functionality score	Up to 12 months
Change in Medication Satisfaction Questionnaire score	Up to 12 months
Proportion of subjects with at least one psychiatric hospitalization	Up to 12 months

Collaborators and Investigators

• Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: August 30, 2010
• First Submitted That Met QC Criteria: August 30, 2010
• First Posted (Estimate): September 1, 2010

Study Record Updates

• Last Update Posted (Estimate): July 8, 2013
• Last Update Submitted That Met QC Criteria: July 4, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Schizophrenia; Aripiprazole; Risperidone; Paliperidone; Quetiapine; Paliperidone palmitate; Haloperidol; Olanzapine; Risperdal; Perphenazine
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Olanzapine; Aripiprazole; Paliperidone Palmitate; Quetiapine Fumarate; Risperidone; Perphenazine
• Other Study ID Numbers: CR017110; R092670SCH4003