CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2011/091/000008 [Registered on: 20/01/2011]

Last Modified On:

23/07/2014

Post Graduate Thesis

Type of Trial

Interventional

Type of Study
Modification(s)

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study
Modification(s)

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

Scientific Title of Study
Modification(s)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder

Trial Acronym

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
NCT01193153	ClinicalTrials.gov
R092670-SCA-3004	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)

Name
Designation
Affiliation
Address
Phone
Fax
Email

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr Shoibal Mukherjee
Designation	Vice President, Medical
Affiliation	Quintiles Research (India) Pvt. Ltd.
Address	8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana India - 122002 Gurgaon HARYANA 122002 India
Phone	91-7838652395
Fax
Email	shoibal.mukherjee@quintiles.com

Details of Contact Person
Public Query
Modification(s)

Name	Suchela Srivatsa
Designation	Director â€“ Clinical Operations
Affiliation	Quintiles Research (India) Pvt. Ltd.
Address	301-A-1, Leela Business Park MV Road, Andheri East, Mumbai 400059 Mumbai MAHARASHTRA 400 059 India
Phone	91-9820712114
Fax	91-22-56774343
Email	suchela.srivatsa@quintiles.com

Source of Monetary or Material Support
Modification(s)

Ortho-McNeil Janssen Scientific Affairs, LLC 1000 Route 202 South Raritan, NJ 08869, USA

Primary Sponsor
Modification(s)

Name	OrthoMcNeil Janssen Scientific Affairs
Address	LLC1000 Route 202 South Raritan, NJ 08869, USA
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor
Modification(s)

Name	Address
Quintiles Research India Private Limited	B-101-106, Shapath IV, Opp. Karnavati Club, Sarkhej â€“ Gandhinagar Road, Ahmedabad 380 051

Countries of Recruitment
Modification(s)

India
Romania
Russian Federation
Ukraine
Bulgaria
Malaysia
Philippines
United States of America

Sites of Study
Modification(s)

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 14
Name of Committee	Approval Status
Central Ethical Committee, Nitte University, Mangalore - Dr. Sateesh Rao	Approved
DMHC Ethics Committee, Varanasi - Dr. Venu Gopal Jhanwar	Approved
Ethical Committee - Sheth V S Hospital, Ahmedabad - Dr. Hitendra Gandhi	Approved
Ethics Committee - Madras Medical College & Government General Hospital, Chennai - Dr. Ramnathan Sathianathan	Approved
Ethics Committee, Shanti Nursing Home, Aurangabad - Dr. Vinay Barhale	Approved
Ethics Committee-Jagadguru Sri Shivaratheeshwara Medical College, Mysore - Dr. Sathyanarayana Rao	Approved
Independent Ethics Committee, Jaipur - Dr. Anil Kumar Tambi	Approved
Institutional Ethics Committee, Chhatrapati Shahuji Maharaj (CSM) Medical University, Lucknow - Dr. Anil Nischal	Approved
Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Reseach Centre, Pune - Dr. Sanjay Phadke	Approved
Lucknow Ethics Committee, Lucknow - Dr. Jitendra Kumar Trivedi	Approved
Maanav Health Foundation Independent Ethics Committee, Vadodara - Dr Sandeep Shah	Approved
North Maharashtra Ethics Committee, Nashik - Dr. Umesh S Nagapurkar	Approved
The Ethics Committee, R K Yadav Memorial Mental Health & De-addiction Hospital, Jaipur - Dr. Rakesh Yadav	Approved
Vijayawada Institute of Mental Health and Neurosciences Hospital-Ethics Committee, Vijayawada- Dr. Vishal Indla	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	Schizoaffective Disorder,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Intervention	Paliperidone palmitate	78, 117, 156, 234 mg (50, 75, 100 or 150 mg eq.) monthly by i.m. injection for up to 21 months (6 months open-label and 15 months double-blind)
Comparator Agent	Placebo	monthly by i.m. injection for up to 15 months

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	- 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

ExclusionCriteria

Details

- 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

Method of Generating Random Sequence
Modification(s)

Computer generated randomization

Method of Concealment
Modification(s)

Centralized

Blinding/Masking
Modification(s)

Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Primary Outcome
Modification(s)

Outcome	TimePoints
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
Modification(s)

Outcome	TimePoints
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

Target Sample Size
Modification(s)

Total Sample Size="520"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial
Modification(s)

Phase 3

Date of First Enrollment (India)
Modification(s)

22/10/2011

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

25/09/2010

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial
Modification(s)

Years="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Open to Recruitment

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

None

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary
Modification(s)

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.