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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
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Colorado, Denver

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

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: Iloperidone Drug: Placebo Phase 2

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Iloperidone

Arm Intervention/treatment
Experimental: Iloperidone / Placebo
During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.
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:
  • Fanapt
  • Fanapta
  • Zomaril

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:
  • Fanapt
  • Fanapta
  • Zomaril

Drug: Placebo
During 8 weeks subjects will receive oral placebo
Other Name: Sugar pill




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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


  7. 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.



Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

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


Locations
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United States, Colorado
University of Colorado Depression Center; Clinical and Translational Research Center (CTRC)
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Michael H Allen, M.D. University of Colorado School of Medicine - Depression Center
Additional Information:
Publications:

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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
Keywords provided by University of Colorado, Denver:
Post traumatic stress disorder
Treatment of post traumatic stress disorder
Symptoms of arousal in post traumatic stress disorder
Iloperidone in post traumatic stress disorder
Additional relevant MeSH terms:
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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