A Study of Paliperidone Palmitate 6-Month Formulation

Conditions

• Schizophrenia

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• PP6M — DRUG
  Participants will receive intramuscular injection of PP6M.
• PP3M 350 mg eq. — DRUG
  Participants will receive intramuscular injection of PP3M 350 mg eq.
• PP3M 525 mg eq. — DRUG
  Participants will receive intramuscular injection of PP3M 525 mg eq.
• PP1M — DRUG
  Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.
• Placebo — OTHER
  Participants will receive matching placebo.

Study Details

The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).

Key Dates

First listed

Nov 17, 2017

Start date

Nov 20, 2017

Status verified

Apr 2025

Primary completion

May 8, 2020

Completion

May 8, 2020

Study Design

Enrollment

841 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PP1M: Transition Phase
  Participants who previously have not achieved stability with moderate to higher doses of Paliperidone palmitate 1-month (PP1M) or Paliperidone palmitate 3-month (PP3M) will enter into a transition period of up to 4 months. During transition period participants will receive 1 to 5 injections of PP1M 50 to 100 milligrams equivalent (mg eq.). The participants who achieved stability (stability is defined as at least 3 months of injections with the last 2 doses being the same strength) with PP1M 100 mg eq. will precede from transition phase to maintenance phase.
• Experimental: PP1M/PP3M: Maintenance Phase
  All the participants will receive only 1 dose of PP1M 100 or 150 mg eq. or PP3M 350 or 525 mg eq. The participants will precede from maintenance phase to double-blind phase.
• Experimental: PP6M or Placebo: Double-Blind Phase
  Participants will receive intramuscular injection of PP6M in left gluteal muscle on Day 1 and right gluteal muscle on Day 183 with alternating placebo in right gluteal muscle on Day 92 and left gluteal muscle on Day 274.
• Experimental: PP3M: Double-Blind Phase
  Participants will receive intramuscular injections of PP3M at dose of 350 mg eq. or 525 mg eq. in left gluteal muscle on Day 1 and 274 and right gluteal muscle on Day 92 and 183.

Primary Outcome Measure

Time to Relapse During the Double-Blind (DB) Phase [ Time Frame: Up to 12 months of DB Phase ]

Locations (25)

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