Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)

A Double-Blind, Placebo-Controlled Random Order Crossover Study of Iloperidone for Symptoms of Arousal in PTSD Including Insomnia and Irritability.

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

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.

Inclusion Criteria:

• PTSD diagnosis

Exclusion Criteria:

• Pregnancy
• Traumatic Brain Injury greater than mild
• Primary sleep disorder
• Caffeinism
• Active substance use disorder
• Active suicidal risk
• Antipsychotic medication, antibiotics, sedatives, some antihypertensive or antiarrhythmic medication