Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)
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ClinicalTrials.gov Identifier: NCT01917318 |
Recruitment Status :
Terminated
(Enrollment challenges - Single participant discontinued after placebo, no relevant outcome measure data was recorded.)
First Posted : August 6, 2013
Results First Posted : January 31, 2020
Last Update Posted : February 11, 2020
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Condition or disease | Intervention/treatment | Phase |
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Post Traumatic Stress Disorder | Drug: Iloperidone Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Placebo-Controlled Random Order Crossover Study of Iloperidone for Symptoms of Arousal in PTSD Including Insomnia and Irritability. |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Iloperidone / Placebo
During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.
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Drug: Iloperidone
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) Other Names:
Drug: Placebo During 8 weeks subjects will receive oral placebo
Other Name: Sugar pill |
Experimental: Placebo / Iloperidone
During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.
|
Drug: Iloperidone
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) Other Names:
Drug: Placebo During 8 weeks subjects will receive oral placebo
Other Name: Sugar pill |
- Change in Clinician Administered PTSD Scale (CAPS) Part B and D [ Time Frame: Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks. ]
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.
- Number of Awakenings [ Time Frame: Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment . ]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.
- Aggression [ Time Frame: Randomization and 8 weeks of treatment, during both treatment periods ]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.
- Sleep Latency [ Time Frame: Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment . ]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
- Wake-time After Sleep Onset (WASO) [ Time Frame: Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment . ]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.
- Suicidal Ideation [ Time Frame: 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 ]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.
- Intensity of Suicidal Ideation [ Time Frame: Baseline ]
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
- Suicidal Behavior [ Time Frame: 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 ]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.

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Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917318
United States, Colorado | |
University of Colorado Depression Center; Clinical and Translational Research Center (CTRC) | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Michael H Allen, M.D. | University of Colorado School of Medicine - Depression Center |
Publications:
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT01917318 |
Other Study ID Numbers: |
13-0207 IIRP-1371 ( Other Identifier: Novartis pharmaceuticals ) |
First Posted: | August 6, 2013 Key Record Dates |
Results First Posted: | January 31, 2020 |
Last Update Posted: | February 11, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Post traumatic stress disorder Treatment of post traumatic stress disorder Symptoms of arousal in post traumatic stress disorder Iloperidone in post traumatic stress disorder |
Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Pathologic Processes Trauma and Stressor Related Disorders Mental Disorders |
Iloperidone Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |