---
title: Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)
nct_id: NCT01917318
overall_status: TERMINATED
phase: PHASE2
sponsor: University of Colorado, Denver
study_type: INTERVENTIONAL
primary_condition: Post Traumatic Stress Disorder
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01917318.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01917318"
ct_last_update_post_date: 2020-02-11
last_seen_at: "2026-05-12T06:53:07.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)

**Official Title:** A Double-Blind, Placebo-Controlled Random Order Crossover Study of Iloperidone for Symptoms of Arousal in PTSD Including Insomnia and Irritability.

**NCT ID:** [NCT01917318](https://clinicaltrials.gov/study/NCT01917318)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Enrollment challenges - Single participant discontinued after placebo, no relevant outcome measure data was recorded.
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1
- **Lead Sponsor:** University of Colorado, Denver
- **Collaborators:** Novartis Pharmaceuticals
- **Conditions:** Post Traumatic Stress Disorder
- **Start Date:** 2013-07
- **Completion Date:** 2014-02
- **CT.gov Last Update:** 2020-02-11

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 89 Years
- **Sex:** ALL
- **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
```

## Arms

- **Iloperidone / Placebo** (EXPERIMENTAL) — During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.
- **Placebo / Iloperidone** (EXPERIMENTAL) — During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.

## 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)
- **Placebo** (DRUG) — During 8 weeks subjects will receive oral placebo

## Primary Outcomes

- **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.

## 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)_

## Locations (1)

- University of Colorado Depression Center; Clinical and Translational Research Center (CTRC), Aurora, Colorado, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of colorado depression center; clinical and translational research center (ctrc)|aurora|colorado|united states` — added _(2026-05-12)_

---

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