A study to evaluate the efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder

Phase 3

Completed

• Conditions: Schizoaffective Disorder

• Registration Number: CTRI/2011/091/000008
• Lead Sponsor: OrthoMcNeil Janssen Scientific Affairs

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of paliperidone palmitate, as monotherapy or as an adjunct to mood stabilizers or antidepressants, relative to placebo in delaying the time to relapse in patients with schizoaffective disorder. The study will consist of 4 periods: Screening (up to 7 days), Open-Label Flexible Dose Lead-in (13 weeks), Open-Label Fixed Dose Stabilization (12 weeks), and Double-Blind Relapse Prevention (15 months). Approximately 520 subjects (approximately 126 in India) are to be enrolled in the open-label Lead-in Period in the USA, Bulgaria, Malaysia, Philippines, Romania, Russia, Ukraine, South Africa and India. Of these 520 subjects, it is expected that approximately 286 subjects will qualify to enter the double-blind Relapse Prevention Period. Efficacy will be evaluated during the study using a relapse assessment, the Positive and Negative Symptom Scale (PANSS), the Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA), the Personal and Social Performance Scale (PSP), the Young Mania Rating Scale (YMRS), and the Hamilton Rating Scale for Depression (HAM-D). Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements (temperature, pulse, and blood pressure), weight, and the monitoring of extrapyramidal symptoms using the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A). Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). The tentative date of enrollment of first patient in India is January 25, 2011.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-22
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• DSM-IV diagnosis of schizoaffective disorder.
• Experiencing an acute exacerbation of psychotic symptoms.
• A score of more than or equual to 4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14).
• A score of more than or equual to 16 on YMRS and/or a score of more than or equual to 16 on the HAM-D-21.
• Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements.

Exclusion Criteria

A primary active mental illness diagnosis other than schizoaffective disorder- Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior- Subjects with first episode of psychosis- Received electroconvulsive therapy in the past 3 months- History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)- Received long-acting antipsychotic medication within 2 injection cycles- Received therapy with clozapine within 3 months- A history of neuroleptic malignant syndrome- Previous history of lack of response to antipsychotic medication- Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening- Receiving therapy with carbamazepine- Receiving therapy with monoamine oxidase inhibitors- Pregnant, breast-feeding, or planning to become pregnant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period	Monthly during the 15 month double-blind Relapse Prevention Period

Secondary Outcome Measures

Name	Time	Method
Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores	Up to 15 Months
Illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA)	Up to 15 Months
Change in subject functioning using the Personal and Social Performance Scale (PSP)	Up to 15 Months
Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ)	Up to 15 Months
Change in mood symptoms as measured by YMRS (in subjects with YMRS=16 at enrollment) and HAM-D-21) (in subjects with HAM-D-21=16 at enrollment)	Up to 15 Months

Trial Locations

Locations (14)

Centre for Psychiatric Research, K.S. Hegde Medical Academy, Mangalore; 🇮🇳 Bangalore, KARNATAKA, India

Chhatrapati Shahuji Maharaj (CSM) Medical University, Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Deenanath Mangeshkar Hospital & Reseach Centre, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Deva Mental Health Care, Varanasi; 🇮🇳 Varanasi, UTTAR PRADESH, India

JSS Medical College & Hospital, Mysore; 🇮🇳 Mysore, KARNATAKA, India

Maanav Health Foundation, C/O Brij Psychiatry Hospital & Muskaan Research Centre; 🇮🇳 Vadodara, GUJARAT, India

Madras Medical College & Government General Hospital, Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Manobal Medical Research Centre Pvt. Ltd., Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Mental Health Care & Research, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

R. K. Yadav Memorial Mental Health & De-addiction Hospital, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

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Centre for Psychiatric Research, K.S. Hegde Medical Academy, Mangalore

🇮🇳Bangalore, KARNATAKA, India

Dr. Sateesh Rao

Principal investigator

dr_satheeshrao@yahoo.com