Generic drug trial to seek approval for Paliperidone injectable suspension for treatment of Schizophrenia or Schizoaffective Disorder.

Not Applicable

Completed

• Conditions: Health Condition 1: F259- Schizoaffective disorder, unspecifiedHealth Condition 2: F209- Schizophrenia, unspecified

• Registration Number: CTRI/2019/08/020588
• Lead Sponsor: Ryan Turncliff

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-02
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 443

Inclusion Criteria

1. Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial.

2. Male or female subjects between 18 and 65 years of age (both inclusive).

3. Subjects having body mass index (BMI) between 18.50 to 30.00 kg/m2 (both inclusive).

4. Subjects diagnosed with schizophrenia or schizoaffective disorder as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria

5. Clinically stable, defined as no psychiatric hospitalizations and no changes in any antipsychotic medication within 3 months prior to study enrollment except for the Lead-in Period

6. Acceptable hematology status:

a. Hemoglobin >= 9 g/dL

b. Absolute neutrophil count (ANC) >= 1500 cells/μL

c. Platelet count >= 100,000 cells/μLprior to dosing.

7. Acceptable liver function:

a. Alanine aminotransferase (ALT) <= 2X upper limit of normal (ULN)

b. Aspartate aminotransferase (AST) <= 2X ULN

c. Bilirubin < 1.2 mg/dL

d. Alkaline phosphatase <= 2X ULN

8. Subjects with creatinine clearance >= 80 mL/minute.

9. Female subjects with negative serum pregnancy test at screening.

10. Subjects who agree to use adequate contraception (e.g., hormonal, chemical, double-barrier, or abstinence) while in the study and for 3 months after study participation is discontinued.

11. Must be able to attend regularly scheduled study center appointments and be able to abide by all study requirements.

12. At the time of randomization, on a stable monthly dose of Paliperidone Palmitate Extended-Release Injectable Suspension, 156 mg (i.e., to have had a minimum of 2 documented monthly maintenance doses administered consecutively in the previous 2 months prior to the first study injection in the Study Treatment Period).

NOTE: The last monthly maintenance injection, prior to entry into the Study Treatment Period, should be administered 28 days (±1 day) prior to randomization.

13. Agree to receive intramuscular injections of Paliperidone Palmitate Extended-Release Injectable Suspension, 156 mg in either the deltoid or the gluteal muscle (as per randomization assignment) for the entirety of the study.

Exclusion Criteria

1. Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients of the formulations.

2. Subjects who are in an acutely agitated or severely psychotic state.

3. Subjects who have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening.

4. Subjects who have a rating of > 4 (moderately ill) on the Clinical Global Impression â?? Severity (CGI-S) scale at screening.

5. History or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinsonâ??s disease or epilepsy/seizures.

6. History or presence of any uncontrolled debilitating systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, etc.)

7. History of documented addiction or substance abuse within 6 months prior to study enrollment.

8. Current or anticipated use during study participation of any of the prohibited medications.

9. Subjects with current or medical history of congenital long QT syndrome (QTc of > 470 msec for females and > 450 msec for males) or presence of severe cardiovascular disease defined as having required cardiovascular surgery or the occurrence of incapacitating myocardial infarction within past 12 months prior to study enrollment.

10. Subjects with history of arrhythmia.

11. Smokers who smoke >= 10 cigarettes or equivalent per day

12. Subjects with positive urine screen for drugs of abuse (except for benzodiazepines which are permissible when supported by a prescription)

NOTE: a positive result in the absence of a valid prescription will be discussed with the Medical Monitor before determining if the subject is to be excluded.

13. Major surgical procedure (including periodontal) within 28 days of first study dose of IP or planned within 9 months

14. Current surgical or other non-healing wounds.

15. Subjects with positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).

16. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study or that could limit adherence to study requirements.

17. Participation in any clinical study within 90 days of IP dosing.

18. Donation and/or loss of >= 350 mL (1 unit) of blood within 90 days of IP dosing.

19. Lactating women.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified