PTSD
Conditions
Brief summary
This open label study will evaluate the safety and efficacy of riluzole in patients with PTSD. Patients will receive riluzole 50mg twice per day orally for 12 weeks as outpatient, with a one month follow up at week 16.
Interventions
DRUGRiluzole
Sponsors
National Center for PTSD
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects between the ages of 18-75 years; * Able to provide written informed consent; * Current Post Traumatic Stress Disorder, as determined by the Clinician Administered Scale for PTSD, or the presence of sub-threshold PTSD. Individuals with sub-threshold PTSD will be included at the discretion of the PI; * Clinician Administered PTSD Scale (CAPS) score of 23 or higher; * Be able to understand and speak English. * Subjects taking FDA-approved antidepressant medications may enter the study if they have been on a stable dose for at least 4 weeks prior to starting the study drug.
Exclusion criteria
* Breastfeeding women and pregnant women, or women of child bearing potential who are not using a medically accepted means of contraception (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy); * Current, ongoing serious suicidal risk as assessed by evaluating investigator or by scoring 5 or more on the item-10 of the MADRS. * Unstable medical illness as determined by the investigator; * Patients with schizophrenia or schizoaffective disorders (current or past); * Substance use disorder during the 3 months prior to screening; except for Cannabis and Alcohol use Disorders. * Clinical evidence of untreated hypothyroidism; * Patients with any evidence of clinically significant liver abnormalities, or any liver transaminase level \> 1.5 x ULN at initial screening, or \> 5 x ULN during treatment; * Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patient's safety or compliance, as determined by the investigator during open-ended psychiatric interview; * Patients currently being treated for a respiratory disorder (including asthma or COPD); * For participants over the age of 60, evidence of dementia as determined by the St. Luis University Mental Status Exam (SLUMS; participants with total scores less than or equal to 20 will be excluded and referred to their Primary Care Physician for follow-up/dementia evaluation); Structured psychotherapy focused on treatment of PTSD is exclusionary unless the subject has had at least 8 weeks of treatment prior to starting the study medication;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Administered PTSD Scale (CAPS) | Change from baseline to 12 weeks | The CAPS is a standardized clinician-rated instrument to assess the presence and severity of PTSD symptoms. The scores range from 0 (minimum) to 80 (mazimum). Higher scores reflect worse symptoms. |
Secondary
| Measure | Time frame |
|---|---|
| Post-Traumatic Stress Disorder Checklist (PCL) | 12 weeks |
| Clinical Global Impressions Scale | 12 weeks |
| Montgomery-Asberg Depression Rating Scale (MADRS) | 12 weeks |
Other
| Measure | Time frame |
|---|---|
| Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Riluzole Open Label Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Riluzole Open Label |
|---|---|
| Age, Continuous | 44.7 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 7 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Change in Clinician Administered PTSD Scale (CAPS)
The CAPS is a standardized clinician-rated instrument to assess the presence and severity of PTSD symptoms. The scores range from 0 (minimum) to 80 (mazimum). Higher scores reflect worse symptoms.
Time frame: Change from baseline to 12 weeks
Population: 18 participants started the study and 9 participants were randomized into the single arm of the study. However, only 8 participants completed the treatment. Since there was some treatment data collected on the 9th participant, he/she was included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Riluzole Open Label | Change in Clinician Administered PTSD Scale (CAPS) | -20.67 units on a scale | Standard Deviation 21.16 |
Secondary
Clinical Global Impressions Scale
Time frame: 12 weeks
Secondary
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 12 weeks
Secondary
Post-Traumatic Stress Disorder Checklist (PCL)
Time frame: 12 weeks
Other Pre-specified
Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR)
Time frame: 12 weeks