Post Traumatic Stress Disorder
Conditions
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
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.
Interventions
DRUGIloperidone
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)
DRUGPlacebo
During 8 weeks subjects will receive oral placebo
Sponsors
Novartis Pharmaceuticals
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Administered PTSD Scale (CAPS) Part B and D | 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
| Measure | Time frame | Description |
|---|---|---|
| Aggression | 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 | 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) | 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. |
| Number of Awakenings | 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. |
| Intensity of Suicidal Ideation | 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 | 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. |
| Suicidal Ideation | 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. |
Countries
United States
Participant flow
Recruitment details
A single participant was enrolled but did not complete the study.
Participants by arm
| Arm | Count |
|---|---|
| Iloperidone / Placebo During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.
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)
Placebo: During 8 weeks subjects will receive oral placebo | 0 |
| Placebo / Iloperidone During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.
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)
Placebo: During 8 weeks subjects will receive oral placebo | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Treatment | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
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.
Time frame: Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks.
Population: Study was terminated due to lack of enrollment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo / Iloperidone | Change in Clinician Administered PTSD Scale (CAPS) Part B and D | CAPS part B at randomization 1 | 20 units on a scale |
| Placebo / Iloperidone | Change in Clinician Administered PTSD Scale (CAPS) Part B and D | CAPS part B after 8 weeks with placebo | 4 units on a scale |
| Placebo / Iloperidone | Change in Clinician Administered PTSD Scale (CAPS) Part B and D | CAPS part B at randomization 2 | 4 units on a scale |
| Placebo / Iloperidone | Change in Clinician Administered PTSD Scale (CAPS) Part B and D | CAPS part B after 2 weeks with iloperidone | 0 units on a scale |
| Placebo / Iloperidone | Change in Clinician Administered PTSD Scale (CAPS) Part B and D | CAPS part D at randomization 1 | 6 units on a scale |
| Placebo / Iloperidone | Change in Clinician Administered PTSD Scale (CAPS) Part B and D | CAPS part D after 8 weeks with placebo | 2 units on a scale |
| Placebo / Iloperidone | Change in Clinician Administered PTSD Scale (CAPS) Part B and D | CAPS part D at randomization 2 | 7 units on a scale |
| Placebo / Iloperidone | Change in Clinician Administered PTSD Scale (CAPS) Part B and D | CAPS part D after 2 weeks with iloperidone | 0 units on a scale |
Secondary
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.
Time frame: Randomization and 8 weeks of treatment, during both treatment periods
Population: Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the Iloperidone / Placebo arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo / Iloperidone | Aggression | MOAS at randomization 1 | 1 units on a scale |
| Placebo / Iloperidone | Aggression | MOAS after 8 weeks with placebo | 0 units on a scale |
| Placebo / Iloperidone | Aggression | MOAS at randomization 2 | 0 units on a scale |
| Placebo / Iloperidone | Aggression | MOAS after 2 weeks with iloperidone treatment | 0 units on a scale |
Secondary
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
Time frame: Baseline
Population: Study was terminated early due to lack of enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo / Iloperidone | Intensity of Suicidal Ideation | 16 score on a scale |
Secondary
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.
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 .
Population: Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Number of Awakenings | Number of awakening at randomization | — |
| Unknown | Number of Awakenings | Number of awakening during placebo treatment | — |
| Unknown | Number of Awakenings | Number of awakening during iloperidone treatment | — |
Secondary
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
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 .
Population: Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Sleep Latency | Sleep latency at randomization | — |
| Unknown | Sleep Latency | Sleep latency during placebo treatment | — |
| Unknown | Sleep Latency | Sleep latency during iloperidone treatment | — |
Secondary
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.
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
Population: Study was terminated due to lack of enrollment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo / Iloperidone | Suicidal Behavior | Lifetime suicidal behavior | 0 participants |
| Placebo / Iloperidone | Suicidal Behavior | 1 month prior ro screening | 0 participants |
| Placebo / Iloperidone | Suicidal Behavior | During the course of the study | 0 participants |
Secondary
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.
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
Population: Study was terminated early due to lack of enrollment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo / Iloperidone | Suicidal Ideation | Lifetime suicidal ideation | 1 participants |
| Placebo / Iloperidone | Suicidal Ideation | 1 month prior to screening | 0 participants |
| Placebo / Iloperidone | Suicidal Ideation | Suicidal ideation during the study | 0 participants |
Secondary
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.
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 .
Population: Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Wake-time After Sleep Onset (WASO) | WASO at randomization | — |
| Unknown | Wake-time After Sleep Onset (WASO) | WASO during placebo treatment | — |
| Unknown | Wake-time After Sleep Onset (WASO) | WASO durinhg iloperidone treatment | — |