Clinical trial NCT01917318: Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)
Official title: A Double-Blind, Placebo-Controlled Random Order Crossover Study of Iloperidone for Symptoms of Arousal in PTSD Including Insomnia and Irritability.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2013-08-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Clinician Administered PTSD Scale (CAPS) Part B and D
timeFrame: Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks.
Secondary outcomes:
measure: Number of Awakenings
timeFrame: Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .
measure: Aggression
timeFrame: Randomization and 8 weeks of treatment, during both treatment periods
measure: Sleep Latency
timeFrame: Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .
measure: Wake-time After Sleep Onset (WASO)
timeFrame: Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .
measure: Suicidal Ideation
timeFrame: Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored
measure: Intensity of Suicidal Ideation
timeFrame: Baseline
measure: Suicidal Behavior
timeFrame: Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Depression Center; Clinical and Translational Research Center (CTRC)
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine - Depression Center
name: Michael H Allen, M.D.
role: PRINCIPAL_INVESTIGATOR
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