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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01917318
• Collaborator: Novartis Pharmaceuticals (Industry)
• Enrollment: 1
• Location: 1
• Arms: 2
• Duration (Months): 7.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jul 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

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 Names: 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 Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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

4. 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.

5. 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.

6. 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

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Michael H Allen, M.D., University of Colorado School of Medicine - Depression Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Depression Center - University of Colorado Denver

Publications

• Citrome L. Iloperidone for schizophrenia: a review of the efficacy and safety profile for this newly commercialised second-generation antipsychotic. Int J Clin Pract. 2009 Aug;63(8):1237-48. doi: 10.1111/j.1742-1241.2009.02142.x. Review.
• David D, De Faria L, Mellman TA. Adjunctive risperidone treatment and sleep symptoms in combat veterans with chronic PTSD. Depress Anxiety. 2006;23(8):489-91.
• Kobayashi I, Boarts JM, Delahanty DL. Polysomnographically measured sleep abnormalities in PTSD: a meta-analytic review. Psychophysiology. 2007 Jul;44(4):660-9. Epub 2007 May 22. Review.
• Krystal JH, Rosenheck RA, Cramer JA, Vessicchio JC, Jones KM, Vertrees JE, Horney RA, Huang GD, Stock C; Veterans Affairs Cooperative Study No. 504 Group. Adjunctive risperidone treatment for antidepressant-resistant symptoms of chronic military service-related PTSD: a randomized trial. JAMA. 2011 Aug 3;306(5):493-502. doi: 10.1001/jama.2011.1080.
• Monnelly EP, Ciraulo DA, Knapp C, Keane T. Low-dose risperidone as adjunctive therapy for irritable aggression in posttraumatic stress disorder. J Clin Psychopharmacol. 2003 Apr;23(2):193-6.
• Raskind MA, Peskind ER, Hoff DJ, Hart KL, Holmes HA, Warren D, Shofer J, O'Connell J, Taylor F, Gross C, Rohde K, McFall ME. A parallel group placebo controlled study of prazosin for trauma nightmares and sleep disturbance in combat veterans with post-traumatic stress disorder. Biol Psychiatry. 2007 Apr 15;61(8):928-34. Epub 2006 Oct 25.
• Reich DB, Winternitz S, Hennen J, Watts T, Stanculescu C. A preliminary study of risperidone in the treatment of posttraumatic stress disorder related to childhood abuse in women. J Clin Psychiatry. 2004 Dec;65(12):1601-6.
• Taylor FB, Martin P, Thompson C, Williams J, Mellman TA, Gross C, Peskind ER, Raskind MA. Prazosin effects on objective sleep measures and clinical symptoms in civilian trauma posttraumatic stress disorder: a placebo-controlled study. Biol Psychiatry. 2008 Mar 15;63(6):629-32. Epub 2007 Sep 14.
• Wicklow A, Espie CA. Intrusive thoughts and their relationship to actigraphic measurement of sleep: towards a cognitive model of insomnia. Behav Res Ther. 2000 Jul;38(7):679-93.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT01917318
• Other Study ID Numbers: 13-0207; IIRP-1371
• First Posted: Aug 6, 2013
• Last Update Posted: Feb 11, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Iloperidone

Study Results

Participant Flow

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

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone
Arm/Group Description	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	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
Period Title: First Treatment
STARTED	0	1
COMPLETED	0	0
NOT COMPLETED	0	1
Period Title: First Treatment
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Change in Clinician Administered PTSD Scale (CAPS) Part B and D
Description	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.

Outcome Measure Data

Analysis Population Description

Study was terminated due to lack of enrollment.

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone
Arm/Group Description	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	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
Measure Participants	0	1
CAPS part B at randomization 1	20
CAPS part B after 8 weeks with placebo	4
CAPS part B at randomization 2	4
CAPS part B after 2 weeks with iloperidone	0
CAPS part D at randomization 1	6
CAPS part D after 8 weeks with placebo	2
CAPS part D at randomization 2	7
CAPS part D after 2 weeks with iloperidone	0

2. Secondary Outcome

Title	Number of Awakenings
Description	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 .

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone
Arm/Group Description	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	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
Measure Participants	0	0

3. Secondary Outcome

Title	Aggression
Description	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

Outcome Measure Data

Analysis Population Description

Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the Iloperidone / Placebo arm.

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone
Arm/Group Description	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	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
Measure Participants	0	1
MOAS at randomization 1	1
MOAS after 8 weeks with placebo	0
MOAS at randomization 2	0
MOAS after 2 weeks with iloperidone treatment	0

4. Secondary Outcome

Title	Sleep Latency
Description	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 .

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone
Arm/Group Description	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	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
Measure Participants	0	0

5. Secondary Outcome

Title	Wake-time After Sleep Onset (WASO)
Description	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 .

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone
Arm/Group Description	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	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
Measure Participants	0	0

6. Secondary Outcome

Title	Suicidal Ideation
Description	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

Outcome Measure Data

Analysis Population Description

Study was terminated early due to lack of enrollment.

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone
Arm/Group Description	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	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
Measure Participants	0	1
Lifetime suicidal ideation	1 Infinity
1 month prior to screening	0 NaN
Suicidal ideation during the study	0 NaN

7. Secondary Outcome

Title	Intensity of Suicidal Ideation
Description	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

Outcome Measure Data

Analysis Population Description

Study was terminated early due to lack of enrollment.

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone
Arm/Group Description	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	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
Measure Participants	0	1
Number [score on a scale]	16

8. Secondary Outcome

Title	Suicidal Behavior
Description	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

Outcome Measure Data

Analysis Population Description

Study was terminated due to lack of enrollment.

Arm/Group Title	Iloperidone / Placebo	Placebo / Iloperidone
Arm/Group Description	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	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
Measure Participants	0	1
Lifetime suicidal behavior	0 NaN
1 month prior ro screening	0 NaN
During the course of the study	0 NaN

Adverse Events

Adverse Event Reporting Description	Study was terminated due to lack of enrollment. No participants were enrolled in the "Iloperidone / Placebo" arm
Arm/Group Title	Iloperidone / Placebo		Placebo / Iloperidone
Arm/Group Description	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		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
All Cause Mortality
	Iloperidone / Placebo		Placebo / Iloperidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)
Serious Adverse Events
	Iloperidone / Placebo		Placebo / Iloperidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Iloperidone / Placebo		Placebo / Iloperidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.