A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01529515
• Date of registration: 06/02/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
• Scientific title: A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia
• Date of first enrolment: May 2012
• Target sample size: 509
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01529515
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Brazil, Bulgaria, Colombia, Korea, Republic of, Malaysia, Mexico, Romania, Russian Federation, South Africa, Turkey, Ukraine, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with schizophrenia for more than 1 year

- A total score in the Positive and Negative Syndrome Scale (PANSS) < 120

- Signed informed consent

- Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice
an effective method of birth control

- Men must agree to use a double-barrier method of birth control

- Be medically stable on the basis of clinical laboratory tests, physical examination,
medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:

- A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder,
major depressive disorder, schizoaffective disorder, schizophreniform disorder,
autistic disorder, primary substance-induced psychotic disorder, dementia-related
psychosis

- Relevant history or current presence of any significant or unstable medical
condition(s) determined to be clinically significant by the Investigator (ie, obesity,
diabetes, heart disease etc)

- A diagnosis of substance dependence within 6 months before screening

- History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia

- Clozapine use in the last 2 months when used for treatment-resistant or
treatment-refractory illness

- Clinically significant findings in biochemistry, hematology, ECG or urinalysis results

- Any other disease or condition that, in the opinion of the investigator, would make
participation not in the best interest of the patient or that could prevent, limit, or
confound the protocol-specified assessments



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: PP3M 175 mg eq.

Drug: Placebo (20% Intralipid emulsion)

Drug: PP3M 263 mg eq.

Drug: PP3M 350 mg eq.

Drug: PP3M 525 mg eq.

Primary Outcome(s)

Time to Relapse During the Double-Blind Phase [Time Frame: Approximately Week 60]

Secondary Outcome(s)

Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase [Time Frame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)]

Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase [Time Frame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)]

Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase [Time Frame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)]

Secondary ID(s)

CR100717

R092670PSY3012

2011-004676-11

U1111-1135-1969

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/06/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01529515