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

NCT01917318 | Terminated Phase 2 Results DMC

• 2 other identifiers: 13-0207IIRP-1371
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Randomization and 8 weeks of treatment, during both treatment periods

• 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 .

• 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 .

• 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

Study Arms (2)

Iloperidone / Placebo

EXPERIMENTAL

During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.

Drug: Iloperidone; Drug: Placebo

Placebo / Iloperidone

EXPERIMENTAL

During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.

Drug: Iloperidone; Drug: Placebo

Interventions

Iloperidone DRUG

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)

Also known as: Fanapt, Fanapta, Zomaril

Iloperidone / Placebo; Placebo / Iloperidone

Placebo DRUG

During 8 weeks subjects will receive oral placebo

Also known as: Sugar pill

Iloperidone / Placebo; Placebo / Iloperidone

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Colorado Depression Center; Clinical and Translational Research Center (CTRC)

Aurora, Colorado, 80045, United States

Location

Related Publications (9)

• 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.

  PMID: 19624791 BACKGROUND

• 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. doi: 10.1002/da.20187.

  PMID: 16845653 BACKGROUND

• 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.

  PMID: 21813427 BACKGROUND

• Kobayashi 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.

  PMID: 17521374 BACKGROUND

• 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. doi: 10.1097/00004714-200304000-00012.

  PMID: 12640221 BACKGROUND

• 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. doi: 10.1016/j.biopsych.2006.06.032. Epub 2006 Oct 25.

  PMID: 17069768 BACKGROUND

• 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. doi: 10.4088/jcp.v65n1204.

  PMID: 15641864 BACKGROUND

• 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. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.

  PMID: 17868655 BACKGROUND

• 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. doi: 10.1016/s0005-7967(99)00136-9.

  PMID: 10875190 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

iloperidone; Sugars

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Michael H. Allen, M.D.
• Organization: University of Colorado

Michael.Allen@ucdenver.edu

(303) 724-3300

Study Officials

• Michael H Allen, M.D.

  University of Colorado School of Medicine - Depression Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 6, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 11, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)