National Adaptive Trial for PTSD Related Insomnia (NAP)
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|ClinicalTrials.gov Identifier: NCT03668041|
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : August 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Drug: Trazodone Drug: Eszopiclone Drug: Gabapentin Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||CSP #2016 - National Adaptive Trial for PTSD Related Insomnia|
|Estimated Study Start Date :||November 16, 2020|
|Estimated Primary Completion Date :||March 15, 2024|
|Estimated Study Completion Date :||March 15, 2024|
Active Comparator: Trazodone
Participants who are assigned to take trazodone, an active study medication.
Trazodone is approved by the Food and Drug Administration (FDA) for treating major depression in adults but not for PTSD. Although trazodone has not been approved by the FDA to treat insomnia or PTSD, some doctors have tried it for these purposes. The doses in this study will be lower than the doses used to treat depression.
Active Comparator: Eszopiclone
Participants who are assigned to take eszopiclone, an active study medication.
Eszopiclone is approved by the FDA for treating insomnia, but it's unknown if eszopiclone can help treat insomnia when it's related to PTSD. Some doctors have tried it for this purpose. The doses in this study will be the same as the doses used to treat insomnia. A small study found it to be helpful for treating patients with PTSD.
Active Comparator: Gabapentin
Participants who are assigned to take gabapentin, an active study medication.
Gabapentin is an FDA approved medication for the treatment of seizures, a type of nerve pain and some forms of chronic pain. Some doctors have prescribed it for insomnia. While the total daily doses in this study are less than the usual total daily dose, the highest dose of gabapentin used in this study will be higher than the typical dose taken at a single time. Doses even higher than this have been taken and observed to be acceptable for treating patients with PTSD.
Placebo Comparator: Placebo
Participants who are assigned to take a placebo, a non-active study medication.
The active study medications listed above will be compared with a placebo, which is a pill that looks like a study medication but has no medication in it.
- Insomnia Severity Index [ Time Frame: Baseline to 12 weeks ]
Change in the Insomnia Severity Index score from baseline to the 12-week follow-up will serve as the primary outcome. Possible range for ISI 0-28. Higher score indicates more severe insomnia problem(s).
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
- Clinician Administered PTSD Scale for DSM-5 [ Time Frame: 12 weeks ]The scale consists of 20 DSM-5 symptoms rated on a 0-4 scale of how much that symptom bothered the individual in the prior month. Possible range for CAPS-5 total score 0-80, CAPS symptom cluster subscores of: Re-experiencing (B) 0-20, Avoidance (C) 0-8, Alteration in Cognition and Mood (D) 0-28, Hyperarousal (E) 0-24, Significant Distress (G) 0-12, and Dissociation (I) 0-8. Higher score indicates more severe PTSD.
- Pittsburgh Sleep Quality Index Scale-Addendum for PTSD [ Time Frame: 12 weeks ]It is a self-administered questionnaire that assesses sleep quality and disturbances over a 1-month period of time. The 7 items in the addendum generate a summary score, with three additional questions if memories or nightmares of a traumatic experience are present. Possible range for PSQI-A score 0-21, and possible range for each item 0-3. Higher PSQI-A score indicates worse quality of sleep.
- Patient Health Questionnaire-9 [ Time Frame: 12 weeks ]It is a tool to measure comorbid depression. This scale is frequently used in VA settings, has been well validated, and is a quick self-administered questionnaire. Possible range for PHQ-9 0-27. Higher score indicates more severe depression. 0-4: None/Minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, 20-27: Severe depression.
- The World Health Organization Quality of Life [ Time Frame: 12 weeks ]It is a 26-item self-administered questionnaire scaled to assess functioning and quality of life. Possible range for WHOQOL-BREF Overall 4-20, WHOQOL-BREF domain subscores of: Physical Health 4-20, Psychological 4-20, Social Relationships 4-20, and Environment 4-20. Higher score indicates better satisfaction with life.
- Treatment Satisfaction Questionnaire for Medication-9 [ Time Frame: 12 weeks ]It is a 9-item questionnaire to measure treatment satisfaction. TSQM-9 are scored on 3 domains: Effectiveness, Convenience, Global Satisfaction. Possible range for TSQM-9 domain scores 0-100. Higher score indicates higher satisfaction with medication.
- Service Utilization and Resources Form [ Time Frame: 12 weeks ]An abbreviated subset of the Service Utilization and Resources Form (SURF) assessment will be used to evaluate alcohol and other substance use (cannabis, smoking, and caffeine) using Timeline Follow-Back and resource utilization (e.g., outpatient medical and/or psychiatric visits and use of inpatient treatment and housing services). Questionnaire; no summary score.
- PTSD Checklist [ Time Frame: 12 weeks ]It is a brief questionnaire measure of PTSD symptom severity that is widely used within and outside VA. Possible range for PCL-5 0-80. Higher score indicates greater propensity for chronic and delayed PTSD.
- Generalized Anxiety Disorder-7 Scale [ Time Frame: 12 weeks ]It is a self-administered tool to assess anxiety. Possible range for GAD-7 0-21. Higher score indicates more severe anxiety disorder. 0-4: None/Minimal anxiety, 5-9: Mild Anxiety, 15-21: Severe anxiety.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668041
|Contact: Beverly A Ventura||(650) 493-5000 ext email@example.com|
|Study Chair:||John H. Krystal, MD||VA Connecticut Healthcare System West Haven Campus, West Haven, CT|