Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sriram Ramaswamy
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- PTSD Symptom Severity
Overview
Brief Summary
The study will evaluate the safety and efficacy of adjunctive minocycline treatment in veterans with PTSD.
Detailed Description
This is a 12-week, open-label pilot study in which adjunctive minocycline will be administered to approximately 15 veterans diagnosed with PTSD.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Veterans between the ages of 19 and 65 who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for chronic PTSD.
- •Patients who have been taking an adequate dose of selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) medication, bupropion, or mirtazapine for a minimum of 8 weeks at the time of study entry.
- •PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score of \> 33 at the Screening Visit. Eligible persons will be allowed to have other symptoms that are commonly comorbid with PTSD (e.g., anxiety, somatic symptoms). This strategy will provide a feasible and generalizable sample of those with chronic PTSD.
Exclusion Criteria
- •Patients with a concurrent DSM-5 diagnosis in any of the following categories:
- •Major Neurocognitive Disorder (NCD) 1.
- •Lifetime Schizophrenia and other Psychotic Disorders 1.
- •Lifetime Bipolar Disorder 1.
- •Alcohol Dependence or Abuse in 3 months prior to the Screening Visit 1.
- •Any other Substance Dependence or Abuse (excluding nicotine) in 12 months prior to the Screening Visit 1.
- •Any other concurrent Axis I Disorder (including Major Depressive Disorder) must be secondary to the primary diagnosis of PTSD.
- •Chronic pain levels requiring use of any opiate medications with the exception of Tramadol. Patients are allowed the use of Tramadol at 25-50 mg per day dosing.
- •Any condition or disorder that may cause neuropsychiatric sequelae (e.g., Parkinson's disease, stroke, seizures, or TBI).
- •Past chronic PTSD, meaning PTSD that preceded the incident traumatic event responsible for the current PTSD. Other traumatic life events will not be exclusionary unless they resulted in previous PTSD.
Arms & Interventions
Minocycline
Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Intervention: Minocycline (Drug)
Outcomes
Primary Outcomes
PTSD Symptom Severity
Time Frame: Baseline and Week 12
PTSD symptom severity was assessed using total scores on the Past Month version of the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5). Total scores on the CAPS-5 range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Change in C-reactive Protein (CRP) Level
Time Frame: Screening and Week 12
Measure of inflammation
Change in Interleukin 6 (IL-6) Level
Time Frame: Screening and Week 12
Measure of inflammation
Change in Tumor Necrosis Factor Alpha (TNF-α) Level
Time Frame: Screening and Week 12
Measure of inflammation
Secondary Outcomes
- Depression Symptom Severity(Screening and Week 12)
- Executive Functioning (Verbal Fluency)(Baseline and Week 12)
- Clinical Status (Severity)(Baseline and Week 12)
- Clinical Status (Improvement)(Baseline and Week 12)
- Executive Functioning (Set Shifting)(Baseline and Week 12)
Investigators
Sriram Ramaswamy
Staff Psychiatrist
VA Nebraska Western Iowa Health Care System