Conditions: Post Traumatic Stress Disorder
Keywords: Post traumatic stress disorder Treatment of post traumatic stress disorder Symptoms of arousal in post traumatic stress disorder Iloperidone in post traumatic stress disorder
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 1
Healthy volunteers: no

Brief summary:
A Double-Blind Placebo-Controlled Random Order Crossover Pilot Study of Iloperidone for Symptoms of Arousal in PTSD.

Detailed description:
During Period A, subjects will receive 8 weeks of iloperidone or placebo (2 weeks titration period followed by 6 weeks on stable dose). Then they will be reassessed for response during Period A; study drug will be discontinued and washed out over the following 2 weeks. They will then begin Period B on the alternate blinded treatment with similar titration and assessment, initially weekly and then every other week for a total of another 8 weeks. The purpose of the study is to determine whether Iloperidone is effective in the treatment of some symptoms in patients with PTSD, particularly difficulty falling or staying asleep, trauma dreams and daytime irritability or outbursts.

Arms:
arm 1: During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo. arm 2: During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.

Interventions: intervention 1: Iloperidone intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.

During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period) intervention 2: During 8 weeks subjects will receive oral placebo

Protocol document: