Conditions: Akathisia, Drug-Induced Antipsychotic Agents Movement Disorders
Keywords: Antipsychotic Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief summary:
This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale.

Detailed description:

Arms:
arm 1: Preladenant 25 mg every 12 hours for 13 days arm 2: Placebo every 12 hours for 13 days arm 3: Preladenant 25 mg every 12 hours for 13 days arm 4: Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)

Interventions: intervention 1: Preladenant intervention 2: Placebo intervention 3: Anticholinergic agents or propanolol intervention 4: Haloperidol
Intervention descriptions: intervention 1: Preladenant, one 25 mg capsule, administered orally every 12 hours intervention 2: Matching placebo capsule administered orally every 12 hours intervention 3: Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue medication at the discretion of the treating physician. Individual anticholinergic agents were not pre-specified per protocol.

Part 2 (standard of care): anticholinergic agents or propanolol at a dose determined by the investigator according to the local standard of care. Individual anticholinergic agents were not pre-specified per protocol. intervention 4: Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day

Protocol document: