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

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

Detailed Description
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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.

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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: Iloperidone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iloperidone / Placebo<br>During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo. | Drug: Iloperidone<br>* 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)<br>* Other names: Zomaril;Drug: Placebo<br>* During 8 weeks subjects will receive oral placebo<br>* Other names: Sugar pill;|
| Experimental: Placebo / Iloperidone<br>During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone. | Drug: Iloperidone<br>* 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)<br>* Other names: Zomaril;Drug: Placebo<br>* During 8 weeks subjects will receive oral placebo<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician Administered PTSD Scale (CAPS) Part B and D | The Clinician-Administered PTSD Scale (CAPS) is a structured interview used to diagnose and assess PTSD. Part B of CAPS evaluates symptoms of re-experiencing. Part D evaluates avoidance and numbing. CAPS-B scores range from 0 to 40 where higher scores indicate more symptoms. A score 0 means no re-experiencing symptoms. CAPS-D scores range form 0 to 56 and higher scores indicate more symptoms. A score 0 means no avoidance or numbing symptoms. The primary endpoint was changes in CAPS part B and D after 8 weeks of treatment. | Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Awakenings | Number of awakenings was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated. There was only 1 value during iloperidone treatment. | Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment . | 
| Aggression | Aggression was measured by the Modified Overt Aggression Scale (MOAS).This assessment measures four types of aggressive behavior (verbal, aggression against property, autoaggression, and physical aggression) . Total scores on the MOAS range from 0-40, with a higher score indicating more aggressive behavior. | Randomization and 8 weeks of treatment, during both treatment periods | 
| Sleep Latency | Sleep latency was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated.There was only 1 value during iloperidone treatment | Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment . | 
| Wake-time After Sleep Onset (WASO) | WASO was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated.There was only 1 value during iloperidone treatment. | Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment . | 
| Suicidal Ideation | The presence of suicidal ideation was monitored over the course of the trial by the first section of the Columbia Suicide Severity Rating Scale (CSSRS). This first section of the scale consists of 5 questions that can be answered yes or no. The number of participants who reported experiencing suicidal ideation is reported. | 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 | 
| Intensity of Suicidal Ideation | Intensity of Suicidal Ideation was monitored over the course of the trial by the second section of the Columbia Suicide Severity Rating Scale (CSSRS). This section is only administered if the patient answers yes to the first section. The section consists of 5 questions that refer to the most severe level of ideation endorsed in the first section of the CSSRS. The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk. Only lifetime intensity of suicidal ideation was explored as the patient had no suicidal ideation from the month prior to beginning the study to the completion of the study | Baseline | 
| Suicidal Behavior | The presence and severity os suicidal behavior was monitored over the course of the trial by the third section of the Columbia Suicide Severity Rating Scale (CSSRS). This sections consists of questions about 5 suicidal behaviors and non-suicidal self injurious behavior and it can be answered yes or no. The number of participants who experienced suicidal behavior is reported. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post traumatic stress disorder, Treatment of post traumatic stress disorder, Symptoms of arousal in post traumatic stress disorder, Iloperidone in post traumatic stress disorder