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Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans

NCT03340350•Sriram Ramaswamy

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. 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.
•3. 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

•1. Patients with a concurrent DSM-5 diagnosis in any of the following categories:
•1.1. Major Neurocognitive Disorder (NCD) 1.2. Lifetime Schizophrenia and other Psychotic Disorders 1.3. Lifetime Bipolar Disorder 1.4. Alcohol Dependence or Abuse in 3 months prior to the Screening Visit 1.5. Any other Substance Dependence or Abuse (excluding nicotine) in 12 months prior to the Screening Visit 1.6. Any other concurrent Axis I Disorder (including Major Depressive Disorder) must be secondary to the primary diagnosis of PTSD.
•2. 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.
•3. Any condition or disorder that may cause neuropsychiatric sequelae (e.g., Parkinson's disease, stroke, seizures, or TBI).
•4. 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.
•5. Patients with a history of intolerance or hypersensitivity to minocycline or other tetracycline antibiotics, or prior tetracycline use 2 months prior to the Screening Visit.
•6. Concomitant treatment with penicillin or other antibiotics, or treatment with antibiotics for greater than 7 days in the past month.
•7. Use of aspirin, non-steroidal anti-inflammatory agents (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors for \< 6 months prior to study entry or dose changes after study entry. Limited as-needed use is permitted prior to study entry but not during the study.
•8. Use of statins will not be permitted during the study as they have been shown to reduce levels of pro-inflammatory cytokines.
•9. Use of concomitant anti-coagulant drugs (except low-dose aspirin) as minocycline has been shown to depress plasma prothrombin activity.
+17 more criteria

Locations (1)

VA Nebraska-Western Iowa Health Care System

Omaha, Nebraska, United States

Key Dates

Start Date

May 10, 2017

Primary Completion Date

June 1, 2018

Completion Date

June 1, 2018

Last Updated

July 9, 2020

Enrollment

ACTUAL participants

Conditions

PTSD

Interventions

Minocycline

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans

Inclusion Criteria

Exclusion Criteria

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