Trial Outcomes & Findings for Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD) (NCT NCT01917318)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks.

Results posted on

2020-02-11

Participant Flow

A single participant was enrolled but did not complete the study.

Participant milestones

Participant milestones
Measure	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	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
First Treatment STARTED	0	1
First Treatment COMPLETED	0	0
First Treatment NOT COMPLETED	0	1
Second Treatment STARTED	0	0
Second Treatment COMPLETED	0	0
Second Treatment NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
First Treatment Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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	Placebo / Iloperidone n=1 Participants 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
Change in Clinician Administered PTSD Scale (CAPS) Part B and D CAPS part B at randomization 1	—	20 units on a scale
Change in Clinician Administered PTSD Scale (CAPS) Part B and D CAPS part B after 8 weeks with placebo	—	4 units on a scale
Change in Clinician Administered PTSD Scale (CAPS) Part B and D CAPS part B at randomization 2	—	4 units on a scale
Change in Clinician Administered PTSD Scale (CAPS) Part B and D CAPS part B after 2 weeks with iloperidone	—	0 units on a scale
Change in Clinician Administered PTSD Scale (CAPS) Part B and D CAPS part D at randomization 1	—	6 units on a scale
Change in Clinician Administered PTSD Scale (CAPS) Part B and D CAPS part D after 8 weeks with placebo	—	2 units on a scale
Change in Clinician Administered PTSD Scale (CAPS) Part B and D CAPS part D at randomization 2	—	7 units on a scale
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 outcome

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 .

Population: Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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	Placebo / Iloperidone n=1 Participants 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
Aggression MOAS at randomization 1	—	1 units on a scale
Aggression MOAS after 8 weeks with placebo	—	0 units on a scale
Aggression MOAS at randomization 2	—	0 units on a scale
Aggression MOAS after 2 weeks with iloperidone treatment	—	0 units on a scale

SECONDARY outcome

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 .

Population: Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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 .

Population: Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Study was terminated early due to lack of enrollment.

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.

Outcome measures

Outcome measures
Measure	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	Placebo / Iloperidone n=1 Participants 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
Suicidal Ideation Lifetime suicidal ideation	—	1 participants
Suicidal Ideation 1 month prior to screening	—	0 participants
Suicidal Ideation Suicidal ideation during the study	—	0 participants

SECONDARY outcome

Timeframe: Baseline

Population: Study was terminated early due to lack of enrollment.

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

Outcome measures

Outcome measures
Measure	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	Placebo / Iloperidone n=1 Participants 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
Intensity of Suicidal Ideation	—	16 score on a scale

SECONDARY outcome

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

Population: Study was terminated due to lack of enrollment.

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.

Outcome measures

Outcome measures
Measure	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	Placebo / Iloperidone n=1 Participants 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
Suicidal Behavior Lifetime suicidal behavior	—	0 participants
Suicidal Behavior 1 month prior ro screening	—	0 participants
Suicidal Behavior During the course of the study	—	0 participants

Adverse Events

Iloperidone / Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo / Iloperidone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael H. Allen, M.D.

University of Colorado

Phone: (303) 724-3300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place