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

University of Colorado Denver (CU Denver)

Status and phase: Terminated; Phase 2

Conditions: Post Traumatic Stress Disorder

Treatments: Drug: Iloperidone; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01917318

IIRP-1371 (Other Identifier)

13-0207

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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1 participants in 2 patient groups

Iloperidone / Placebo

Experimental group

Description:

During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.

Treatment:

Drug: Placebo

Drug: Iloperidone

Placebo / Iloperidone

Experimental group

Description:

During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.

Treatment:

Drug: Placebo

Drug: Iloperidone