Post Traumatic Stress DisorderPhase 2NCT01917318
Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)
A Phase 2 study testing Iloperidone in people with Post Traumatic Stress Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
A Double-Blind Placebo-Controlled Random Order Crossover Pilot Study of Iloperidone for Symptoms of Arousal in PTSD. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Iloperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Depression Center; Clinical and Translational Research Center (CTRC)
Aurora, Colorado, 80045
About this study
Official title: A Double-Blind, Placebo-Controlled Random Order Crossover Study of Iloperidone for Symptoms of Arousal in PTSD Including Insomnia and Irritability.
A Double-Blind Placebo-Controlled Random Order Crossover Pilot Study of Iloperidone for Symptoms of Arousal in PTSD.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Iloperidone, Placebo
- 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
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloperidoneDrug
Also called Fanapt, Fanapta, Zomaril
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)
PlaceboDrug
Also called Sugar pill
During 8 weeks subjects will receive oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Iloperidone / Placebo | Experimental | During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo. Receives: Drug: Iloperidone; Drug: Placebo |
| Placebo / Iloperidone | Experimental | During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone. Receives: Drug: Iloperidone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks.
Secondary outcomes (7)
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.
Measured: Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .
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.
Measured: Randomization and 8 weeks of treatment, during both treatment periods
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
Measured: Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .
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.
Measured: Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .
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.
Measured: 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
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
Measured: Baseline
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Enrollment challenges - Single participant discontinued after placebo, no relevant outcome measure data was recorded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Michael H Allen, M.D., Principal investigator, University of Colorado School of Medicine - Depression Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917318
- Sponsor's protocol ID
- 13-0207
- Other IDs
- IIRP-1371
- Status last verified
- Jan 2020
- First submitted
- 31 Jul 2013
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 19624791David 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. doi: 10.1002/da.20187.
PubMed 16845653Krystal 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.
PubMed 21813427Kobayashi I, Boarts JM, Delahanty DL. Polysomnographically measured sleep abnormalities in PTSD: a meta-analytic review. Psychophysiology. 2007 Jul;44(4):660-9. doi: 10.1111/j.1469-8986.2007.537.x. Epub 2007 May 22.
PubMed 17521374Monnelly 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. doi: 10.1097/00004714-200304000-00012.
PubMed 12640221Raskind 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. doi: 10.1016/j.biopsych.2006.06.032. Epub 2006 Oct 25.
PubMed 17069768Reich 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. doi: 10.4088/jcp.v65n1204.
PubMed 15641864Taylor 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. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.
PubMed 17868655Wicklow 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. doi: 10.1016/s0005-7967(99)00136-9.
PubMed 10875190
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Random Order Crossover Study of Iloperidone for Symptoms of Arousal in PTSD Including Insomnia and Irritability.
- ClinicalTrials.gov ID
- NCT01917318
- Acronym / sponsor ID
- 13-0207
- Conditions
- Post Traumatic Stress Disorder
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment challenges - Single participant discontinued after placebo, no relevant outcome measure data was recorded.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iloperidone / Placebo | Experimental | Drug: Iloperidone, Drug: PlaceboDuring 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo. |
| Placebo / Iloperidone | Experimental | Drug: Iloperidone, Drug: PlaceboDuring 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PTSD diagnosis
Key exclusion criteria (7 listed)
- Pregnancy
- Traumatic Brain Injury greater than mild
- Primary sleep disorder
- Caffeinism
- Active substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IloperidoneAlso: Fanapt, Fanapta, ZomarilSubjects 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) | Drug | Iloperidone / Placebo, Placebo / Iloperidone |
| PlaceboAlso: Sugar pillDuring 8 weeks subjects will receive oral placebo | Drug | Iloperidone / Placebo, Placebo / Iloperidone |
Primary outcome
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.
7 secondary outcomes
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 .
Aggression
Time frame: Randomization and 8 weeks of treatment, during both treatment periods
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 .
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 .
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
Intensity of Suicidal Ideation
Time frame: Baseline
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19624791Citrome 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.
- Background: PubMed 16845653David 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. doi: 10.1002/da.20187.
- Background: PubMed 21813427Krystal 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.
- Background: PubMed 17521374Kobayashi I, Boarts JM, Delahanty DL. Polysomnographically measured sleep abnormalities in PTSD: a meta-analytic review. Psychophysiology. 2007 Jul;44(4):660-9. doi: 10.1111/j.1469-8986.2007.537.x. Epub 2007 May 22.
- Background: PubMed 12640221Monnelly 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. doi: 10.1097/00004714-200304000-00012.
- Background: PubMed 17069768Raskind 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. doi: 10.1016/j.biopsych.2006.06.032. Epub 2006 Oct 25.
- Background: PubMed 15641864Reich 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. doi: 10.4088/jcp.v65n1204.
- Background: PubMed 17868655Taylor 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. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.
- Background: PubMed 10875190Wicklow 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. doi: 10.1016/s0005-7967(99)00136-9.
- Depression Center - University of Colorado DenverLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Allen, M.D. principal investigator
University of Colorado School of Medicine - Depression Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iloperidone in people with Post Traumatic Stress Disorder, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01917318, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.