PTSDPhase 4NCT03340350
Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans
A Phase 4 study testing Minocycline in people with PTSD, run by Sriram Ramaswamy at 1 site in United States.
Trial summary
The study will evaluate the safety and efficacy of adjunctive minocycline treatment in veterans with PTSD. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 1 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- 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.
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- Concomitant treatment with penicillin or other antibiotics, or treatment with antibiotics for greater than 7 days in the past month.
- 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.
- Use of statins will not be permitted during the study as they have been shown to reduce levels of pro-inflammatory cytokines.
- Use of concomitant anti-coagulant drugs (except low-dose aspirin) as minocycline has been shown to depress plasma prothrombin activity.
- Any degree of hepatic or renal failure that in the Investigator's judgement would pose a safety risk for treatment with minocycline.
- Conditions which may be negatively affected by minocycline treatment, such as active inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease).
- A history of C. difficile colitis.
- Patients who based on history or mental status examination have a significant risk of committing suicide, or who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
- Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.
- Women who are pregnant or plan to become pregnant during the study. All women of childbearing potential must have a negative urine pregnancy test at the Screening Visit and throughout the study. Sexually active women participating in the study must use a medically acceptable form of contraception.
- Patients with a current known infection or who are acutely ill.
- Patients with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis).
- Immunocompromised patients (i.e., HIV).
- Patients with thyroid disorders unless euthyroid at screening.
- Patients with cancer not in remission.
- Patients with cardiovascular disease, such as myocardial infarction and arrhythmias.
- Patients with diabetes.
- History of significant esophagitis.
- Patients who plan to initiate or terminate any psychotropic medication during the study. Patients taking any psychotropic medication should be on a stable dose for at least 6 weeks prior to the Screening Visit (except for the SSRI, SNRI or mirtazapine used to treat their PTSD) AND agree not to discontinue or otherwise alter treatment during the study.
- Patients who plan to initiate or terminate any form of psychotherapy or behavior therapy during the study with the exception of PTSD Orientation Group. Subjects may be in supportive psychotherapy if it was initiated at least three months prior to the Screening Visit AND subject agrees not to discontinue or otherwise alter therapy during the study. Subjects receiving evidence-based psychotherapies such as Prolonged Exposure or Cognitive Processing Therapy will be excluded.
- Patients who are unable to speak, read, and understand English or are judged by the Investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Nebraska-Western Iowa Health Care System
Omaha, Nebraska, 68105
About this study
The study will evaluate the safety and efficacy of adjunctive minocycline treatment in veterans with PTSD.
Read the 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.
- Conditions
- PTSD
- Being tested
- Minocycline
- Keywords
- Minocycline, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Minocycline hydrochloride capsule
Minocycline capsule
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12 Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptom Severity
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.
Measured: Baseline and Week 12
Change in C-reactive Protein (CRP) Level
Measure of inflammation
Measured: Screening and Week 12
Change in Interleukin 6 (IL-6) Level
Measure of inflammation
Measured: Screening and Week 12
Change in Tumor Necrosis Factor Alpha (TNF-α) Level
Measure of inflammation
Measured: Screening and Week 12
Secondary outcomes (5)
Depression Symptom Severity
Depression symptom severity was assessed using total scores on the Beck Depression Inventory-II (BDI-II). Total scores on the BDI-II range from 0 to 63, with higher scores indicating greater severity of depression symptoms.
Measured: Screening and Week 12
Clinical Status (Severity)
The Clinical Global Impressions Severity scale (CGI-S) was used to assess severity of illness. Scores on the CGI-S range from 0 to 7, with higher scores reflecting greater severity of illness.
Measured: Baseline and Week 12
Clinical Status (Improvement)
The Clinical Global Impressions Improvement scale (CGI-I) was used to assess global improvement in clinical status. Scores on the CGI-I range from 0 to 7, with lower scores reflecting greater improvement in clinical status.
Measured: Baseline and Week 12
Executive Functioning (Set Shifting)
The Trail Making Test (TMT) is a scale used to measure a type of executive functioning (i.e., higher-order cognitive function) called set shifting. The TMT is scored as time (in seconds) to complete Parts A and B of this task. A difference score was calculated (time to complete Part B minus time to complete Part A) to subtract the motor component of this task and provide a better estimate of executive functioning. Lower difference scores on the TMT indicate better set shifting.
Measured: Baseline and Week 12
Executive Functioning (Verbal Fluency)
The Controlled Oral Word Association (COWA) is a scale used to measure a type of executive functioning (i.e., higher-order cognitive function) called verbal fluency. The COWA is scored as the total number of valid words produced in one minute for each of three letters, with 1 point scored for each valid word (score range: 0-no upper limit). Higher scores on the COWA indicate greater verbal fluency.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start10 May 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sriram Ramaswamy
- Sponsor type
- US federal agency
- Collaborators
- Creighton University
- Responsible party
- Sponsor-investigator, Sriram Ramaswamy, VA Nebraska Western Iowa Health Care System
- Investigators
- Sriram Ramaswamy, MD, Principal investigator, VA Nebraska Western Iowa Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340350
- Sponsor's protocol ID
- RAM-01068
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2017
- Last updated
- 9 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans
- ClinicalTrials.gov ID
- NCT03340350
- Acronym / sponsor ID
- RAM-01068
- Conditions
- PTSD
- Keywords
- Minocycline, PTSD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sriram RamaswamyUS federal agency
- Collaborators
- Creighton University
- Study start
- 10 May 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 17 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineMinocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineAlso: Minocycline hydrochloride capsuleMinocycline capsule | Drug | Minocycline |
Primary outcome
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
5 secondary outcomes
Depression Symptom Severity
Time frame: Screening and Week 12
Clinical Status (Severity)
Time frame: Baseline and Week 12
Clinical Status (Improvement)
Time frame: Baseline and Week 12
Executive Functioning (Set Shifting)
Time frame: Baseline and Week 12
Executive Functioning (Verbal Fluency)
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriram Ramaswamy, MD principal investigator
VA Nebraska Western Iowa Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minocycline in people with PTSD, run by Sriram Ramaswamy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptom Severity (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.