Gabapentin for Insomnia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
InsomniaEszopiclone - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if taking medications for insomnia can help decrease symptoms of PTSD.

Eligible Conditions
  • Insomnia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 12 weeks

12 weeks
Clinician Administered PTSD Scale for DSM-5
Generalized Anxiety Disorder-7 Scale
PTSD Checklist
Patient Health Questionnaire-9
Pittsburgh Sleep Quality Index Scale-Addendum for PTSD
Service Utilization and Resources Form
The World Health Organization Quality of Life
Treatment Satisfaction Questionnaire for Medication-9
Baseline to 12 weeks
Insomnia Severity Index

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Gabapentin
1 of 4
Trazodone
1 of 4
Eszopiclone
1 of 4
Placebo
1 of 4

Active Control

Non-Treatment Group

1224 Total Participants · 4 Treatment Groups

Primary Treatment: Gabapentin · Has Placebo Group · Phase 3

Gabapentin
Drug
ActiveComparator Group · 1 Intervention: Gabapentin · Intervention Types: Drug
Trazodone
Drug
ActiveComparator Group · 1 Intervention: Trazodone · Intervention Types: Drug
Eszopiclone
Drug
ActiveComparator Group · 1 Intervention: Eszopiclone · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,485 Previous Clinical Trials
2,740,995 Total Patients Enrolled
25 Trials studying Insomnia
3,559 Patients Enrolled for Insomnia
John H. Krystal, MDStudy ChairVA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 Previous Clinical Trials
163 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 18 and 75 years.
You have a total CAPS-5 score of 26 or higher.
You are willing to comply with all study procedures and are available for the duration of the study.
You have a primary diagnosis of PTSD, assessed by structured interview using the CAPS-5.

Who else is applying?

What state do they live in?
Oklahoma66.7%
California33.3%
What site did they apply to?
VA Long Beach Healthcare System, Long Beach, CA50.0%
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria33.3%
Met criteria66.7%