PTSD - Post Traumatic Stress DisorderNCT07717866
Trifecta Research Study
An observational study of PTSD - Post Traumatic Stress Disorder and Cognitive Dysfunction, run by Axial Therapeutic Research at 1 site in United States.
Trial summary
This observational study evaluates the impact of Ibogaine-Magnesium (IM), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), Magnetic e-Resonance Therapy (MeRT), and Physiological Supplementation (PS) on posttraumatic stress disorder (PTSD) and traumatic brain injury-related cognitive symptoms among Special Operations… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Injury
- What is being tested?
- Magnetic e-Resonance Therapy (MeRT), Ibogaine Hydrochloride with Magnesium Sulfate and 5-methoxy-N,N-dimethyltryptamine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were obtained from a cohort of treatment-seeking SOF veterans with problems in mental health including PTSD, cognitive symptoms related to traumatic brain injury, depression, and suicidality. Participants were selected and sponsored by SOC-F.
Who may be able to join
- At least 18 years of age
- Sponsored by SOC-F Program
- Exclusion Criteria (evaluated by SOC-F, not Axial Therapeutic Research):
- Diagnosis of Schizophrenia, Bipolar I or II disorder for which patient has been hospitalized or medicated, Depersonalization and/or Derealization Disorder
- Cerebellar dysfunction, Epilepsy, Psychosis or acute confusional state, Dementia
- Prolonged corrected QT interval (QTc) Interval (450ms in males; 470ms in females)
Show all 14Show fewer
- History of heart failure or hypertrophic heart
- Active blood clots (e.g., Pulmonary embolism, Deep vein thrombosis)
- Major respiratory conditions (e.g., Emphysema, Cystic fibrosis)
- Severe chronic gastrointestinal issues (e.g., bleeding ulcer, leaky gut syndrome)
- Within 6 months of surgeries
- Abnormal blood test results (e.g., potassium or magnesium outside normal range)
- Impaired kidney or liver function
- Refusal to taper off of selective serotonin reuptake inhibitor (SSRI) medication
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Axial Therapeutic Research
Northridge, California, 91325
About this study
Official title: Trifecta Research Study - An Observational Study Evaluating the Impact of Ibogaine-Magnesium, 5-MeO-DMT, Magnetic e-Resonance Therapy, and Physiological Supplementation in Special Operations Forces Combat Veterans
This observational study evaluates the impact of Ibogaine-Magnesium (IM), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), Magnetic e-Resonance Therapy (MeRT), and Physiological Supplementation (PS) on posttraumatic stress disorder (PTSD) and traumatic brain injury-related cognitive symptoms among Special Operations Forces (SOF) combat veterans.
Read the detailed description
Approximately forty participants took part in a program of experimental interventions and therapies that was created to improve psychological and cognitive health outcomes in a population with severe, treatment-resistant conditions. Participants were obtained from a cohort of SOF veterans who were already seeking these therapies through the Special Operations Care-Fund (SOC-F) and chose to volunteer for the study. Participants were assigned by SOC-F to one of two sequences of interventions through SOC-F's care providers. One group received PS, then MeRT, then IM and 5-MeO-DMT. The other group received PS, then IM and 5-MeO-DMT, then MeRT. PS preceded the other interventions in each condition. The study design includes self-report and informant-report questionnaires and cognitive task assessments, all of which monitor the interventions' impact on health outcomes. The general purpose is to explore the potential for this combination of treatments to improve mental health and cognitive function. A collection of subjective and objective data will allow a comprehensive assessment of therapeutic impact, with the ultimate goal of informing future clinical trials and veteran treatment services. This project was formerly registered on clinicaltrials.gov (NCT06810765).
Aims and Hypotheses:
Aim 1: Investigate the impact of all interventions on PTSD symptoms and cognitive function in SOF veterans with PTSD and cognitive difficulties.
H1.1. Collectively, program interventions will be associated with reduced self-reported PTSD symptoms at 3-month follow-up (3MFU).
H1.2. Collectively, program interventions will be associated with improved self-reported cognitive functioning at 3MFU.
H1.3. Collectively, program interventions will be associated with improved cognitive inhibition, indexed by the Stroop Squared Task, at Post-treatment.
H1.4. Collectively, program interventions will be associated with improved negative emotional memory, indexed by a higher proportion of recalled positive words (see V1.1 in Dependent Variable section) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment.
H1.5. Collectively, program interventions will be associated with improved positive emotional memory, indexed by a higher proportion of recalled positive words (V1.2) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment.
H1.6. Collectively, program interventions will be associated with improved negative emotional memory, indexed by a higher proportion of negative recall intrusions (V2.1) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment.
Aim 2: Investigate the incremental impact of IM and 5-Meo-DMT on PTSD symptoms and cognitive functioning relative to initial intervention with PS and MeRT in SOF veterans with PTSD and cognitive difficulties.
H2.1. IM/5-Meo-DMT will be associated with an incremental reduction in self-reported PTSD symptoms at 3MFU, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint).
H2.2. IM/5-Meo-DMT will be associated with an incremental improvement in self-reported cognitive functioning at 3MFU, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint).
H2.3. IM/5-Meo-DMT will be associated with an incremental improvement in cognitive inhibition at Post-treatment, indexed by the Stroop Squared Task, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint).
Aim 3: Investigate whether the sequence of interventions differentially impacts PTSD and cognitive functioning at 3MFU in SOF veterans. No formal hypotheses.
Aim 4: Investigate adverse events related to each of the interventions. No formal hypotheses.
- Conditions
- PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Injury, Depression - Major Depressive Disorder, Suicidal Ideation
- Being tested
- Magnetic e-Resonance Therapy (MeRT), Ibogaine Hydrochloride with Magnesium Sulfate, 5-methoxy-N,N-dimethyltryptamine, Physiological Supplementation
- Keywords
- ibogaine, psychedelic, MeRT, special operations, veteran, PTSD, depression, TBI, TMS, suicidal ideation, suicidality
- Medical subject headings
- Combat Disorders, Cognitive Dysfunction, Brain Injuries, Suicidal Ideation, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic e-Resonance Therapy (MeRT)Device
MeRT, an electroencephalography (EEG)-guided Repetitive Transcranial Magnetic Stimulation therapy, is a non-invasive treatment that uses magnetic pulses to modulate neural networks of the brain, guided by an individual's brain patterns. MeRT is a neuromodulatory tool that has shown therapeutic efficacy in relation to decreasing severity of PTSD symptoms. There is preliminary data showing MeRT's therapeutic impact on depression and TBI-related cognitive impairment through promoting cortical excitability, modulating neurotransmission, and restoring neuroplasticity.
Ibogaine Hydrochloride with Magnesium SulfateDrug
Ibogaine hydrochloride was administered orally. Ibogaine is an indole alkaloid that together with its metabolites interacts with mu opioid, kappa opioid, N-methyl-D-aspartate receptor (NMDA), and nicotinic acetylcholine receptors. Ibogaine has shown early signs of effectiveness as a rapid-acting treatment for a number of mental health disorders including PTSD and substance use disorder.
Magnesium sulfate was administered intravenously prior to Ibogaine administration and orally each day.
5-methoxy-N,N-dimethyltryptamineDrug
5-MeO-DMT is administered by using a pipe to inhale a vapor that is produced by heating a canister containing a powder form of the substance. 5-MeO-DMT is a 5-HT-1A and 5-HT-2A agonist compound that has shown early signs of effectiveness in treating depression. Inhaled 5-MeO-DMT has a short duration of action, producing an intense, time-limited psychoactive state.
Physiological SupplementationDrug
Physiological Supplementation describes a treatment program aimed at restoring healthy endocrine functioning, using supplements such as the following: Synthetic testosterone, Anastrozole, Gonadorelin, Vitamin and amino acid supplementation, Fish oil, Ipamorelin.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Sequence 1 | Individuals in this arm will undergo Physiological Supplementation, then Ibogaine and 5-MeO treatment, and then MeRT therapy. Receives: Device: Magnetic e-Resonance Therapy (MeRT); Drug: Ibogaine Hydrochloride with Magnesium Sulfate; Drug: 5-methoxy-N,N-dimethyltryptamine; Drug: Physiological Supplementation | |
| Intervention Sequence 2 | Individuals in this arm will undergo Physiological Supplementation, then MeRT therapy, and then Ibogaine and 5-MeO-DMT. Receives: Device: Magnetic e-Resonance Therapy (MeRT); Drug: Ibogaine Hydrochloride with Magnesium Sulfate; Drug: 5-methoxy-N,N-dimethyltryptamine; Drug: Physiological Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL-5)
The PTSD Checklist for DSM-5 (PCL-5) is a self-report questionnaire designed to assess the severity of PTSD symptoms in alignment with the DSM-5 diagnostic criteria. A total symptom severity score (range - 0-80) will be obtained by summing the scores for each of the 20 items with higher scores indicating greater symptom severity. Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3 month follow up (MFU), 6MFU, 12MFU.
Measured: Up to 12 months follow up
Medical Outcomes Study Cognitive Functioning Scale (MOS-CF)
The Medical Outcomes Study - Cognitive Functioning (MOS-CF) self-report scale consists of 6 items that are designed to measure perceived cognitive functioning. Each item is scored on a 6-point scale (1-6), with 1 being 'all of the time' and 6 being 'none of the time.' Higher scores indicate higher cognitive functioning and lower cognitive symptoms. Collected - Group/Sequence 1: Baseline, pre-HRT, pre-MeRT, mid-MeRT (week 3 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group/Sequence 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
Measured: Up to 12 months follow up
Stroop Squared Task
In the Stroop Squared Task, participants will select words corresponding to the color of the stimulus word given. For example, participants will name the color of the ink a word is printed in while ignoring the word itself (e.g., the word "BLUE" printed in red ink). The task primarily measures cognitive inhibition. Each participant will receive one score indexing the delay in reaction time caused by the mismatch between word and color.
Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3MFU, 6MFU, 12MFU.
Measured: Up to 12 months follow-up
Externalized Free Recall with Emotional Words Task
In the Externalized Free Recall with Emotional Words Task, participants will be presented with a series of emotionally positive, negative, and neutral stimuli (e.g., words or images) and asked to recall the stimuli. The task captures how well individuals retain and recall emotional versus neutral content. Dependent variables include:
V1. The proportion of total words correctly recalled of total words administered V1.1. The proportion of recalled negative words of all words recalled V1.2. The proportion of recalled positive words of all words recalled V1.3. The proportion of recalled neutral words of all words recalled V2. The absolute number of total recall intrusions V2.1. The proportion of intruding negative words of all intruding words V2.2. The proportion of intruding positive words of all intruding words V2.3. The proportion of intruding neutral words of all intruding words Data Collected: Group/Sequence A: pre-PS, Post-MeRT; Group/Sequence B: pre-PS, post-IM/5Meo.
Measured: Up to 15 weeks (Post-MeRT for Group A, Post-IM/5MeO for Group B)
Secondary outcomes (2)
Depressive Symptom Index-Suicidality Subscale (DSI-SS)
The DSI-SS assesses the severity of suicide ideation. The measure consists of 4 items, each with a Likert-type scale (0-4) indicating the frequency and severity of different aspects of suicidal ideation (e.g., planfulness, control, impulse). Higher scores indicate greater levels of suicidal ideation. Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3MFU, 6MFU, 12MFU.
Measured: Up to 12 month follow-up
Adverse Events
Adverse event questions are administered at post-treatment and follow-up. Worsening suicidality (as indexed by the DSI-SS) following the first intervention will be logged as an adverse event.
Measured: Up to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Aug 2022
- Primary completion1 Feb 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axial Therapeutic Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- I S Kroop, Study director, Axial Therapeutic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717866
- Sponsor's protocol ID
- 65357
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trifecta Research Study - An Observational Study Evaluating the Impact of Ibogaine-Magnesium, 5-MeO-DMT, Magnetic e-Resonance Therapy, and Physiological Supplementation in Special Operations Forces Combat Veterans
- ClinicalTrials.gov ID
- NCT07717866
- Acronym / sponsor ID
- 65357
- Conditions
- PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Injury, Depression - Major Depressive Disorder, Suicidal Ideation
- Keywords
- ibogaine, psychedelic, MeRT, special operations, veteran, PTSD, depression, TBI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Axial Therapeutic ResearchIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study evaluates the impact of Ibogaine-Magnesium (IM), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), Magnetic e-Resonance Therapy (MeRT), and Physiological Supplementation (PS) on posttraumatic stress disorder (PTSD) and traumatic brain injury-related cognitive symptoms among Special Operations Forces (SOF) combat veterans.
Detailed description
Approximately forty participants took part in a program of experimental interventions and therapies that was created to improve psychological and cognitive health outcomes in a population with severe, treatment-resistant conditions. Participants were obtained from a cohort of SOF veterans who were already seeking these therapies through the Special Operations Care-Fund (SOC-F) and chose to volunteer for the study. Participants were assigned by SOC-F to one of two sequences of interventions through SOC-F's care providers. One group received PS, then MeRT, then IM and 5-MeO-DMT. The other group received PS, then IM and 5-MeO-DMT, then MeRT. PS preceded the other interventions in each condition. The study design includes self-report and informant-report questionnaires and cognitive task assessments, all of which monitor the interventions' impact on health outcomes. The general purpose is to explore the potential for this combination of treatments to improve mental health and cognitive function. A collection of subjective and objective data will allow a comprehensive assessment of therapeutic impact, with the ultimate goal of informing future clinical trials and veteran treatment services. This project was formerly registered on clinicaltrials.gov (NCT06810765).
Aims and Hypotheses:
Aim 1: Investigate the impact of all interventions on PTSD symptoms and cognitive function in SOF veterans with PTSD and cognitive difficulties.
H1.1. Collectively, program interventions will be associated with reduced self-reported PTSD symptoms at 3-month follow-up (3MFU).
H1.2. Collectively, program interventions will be associated with improved self-reported cognitive functioning at 3MFU.
H1.3. Collectively, program interventions will be associated with improved cognitive inhibition, indexed by the Stroop Squared Task, at Post-treatment.
H1.4. Collectively, program interventions will be associated with improved negative emotional memory, indexed by a higher proportion of recalled positive words (see V1.1 in Dependent Variable section) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment.
H1.5. Collectively, program interventions will be associated with improved positive emotional memory, indexed by a higher proportion of recalled positive words (V1.2) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment.
H1.6. Collectively, program interventions will be associated with improved negative emotional memory, indexed by a higher proportion of negative recall intrusions (V2.1) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment.
Aim 2: Investigate the incremental impact of IM and 5-Meo-DMT on PTSD symptoms and cognitive functioning relative to initial intervention with PS and MeRT in SOF veterans with PTSD and cognitive difficulties.
H2.1. IM/5-Meo-DMT will be associated with an incremental reduction in self-reported PTSD symptoms at 3MFU, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint).
H2.2. IM/5-Meo-DMT will be associated with an incremental improvement in self-reported cognitive functioning at 3MFU, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint).
H2.3. IM/5-Meo-DMT will be associated with an incremental improvement in cognitive inhibition at Post-treatment, indexed by the Stroop Squared Task, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint).
Aim 3: Investigate whether the sequence of interventions differentially impacts PTSD and cognitive functioning at 3MFU in SOF veterans. No formal hypotheses.
Aim 4: Investigate adverse events related to each of the interventions. No formal hypotheses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Sequence 1 | – | Device: Magnetic e-Resonance Therapy (MeRT), Drug: Ibogaine Hydrochloride with Magnesium Sulfate, Drug: 5-methoxy-N,N-dimethyltryptamine, Drug: Physiological SupplementationIndividuals in this arm will undergo Physiological Supplementation, then Ibogaine and 5-MeO treatment, and then MeRT therapy. |
| Intervention Sequence 2 | – | Device: Magnetic e-Resonance Therapy (MeRT), Drug: Ibogaine Hydrochloride with Magnesium Sulfate, Drug: 5-methoxy-N,N-dimethyltryptamine, Drug: Physiological SupplementationIndividuals in this arm will undergo Physiological Supplementation, then MeRT therapy, and then Ibogaine and 5-MeO-DMT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were obtained from a cohort of treatment-seeking SOF veterans with problems in mental health including PTSD, cognitive symptoms related to traumatic brain injury, depression, and suicidality. Participants were selected and sponsored by SOC-F.
Key inclusion criteria (14 listed)
- At least 18 years of age
- Sponsored by SOC-F Program
- Diagnosis of Schizophrenia, Bipolar I or II disorder for which patient has been hospitalized or medicated, Depersonalization and/or Derealization Disorder
- Cerebellar dysfunction, Epilepsy, Psychosis or acute confusional state, Dementia
- Prolonged corrected QT interval (QTc) Interval (450ms in males; 470ms in females)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Magnetic e-Resonance Therapy (MeRT)MeRT, an electroencephalography (EEG)-guided Repetitive Transcranial Magnetic Stimulation therapy, is a non-invasive treatment that uses magnetic pulses to modulate neural networks of the brain, guided by an individual's brain patterns. MeRT is a neuromodulatory tool that has shown therapeutic efficacy in relation to decreasing severity of PTSD symptoms. There is preliminary data showing MeRT's therapeutic impact on depression and TBI-related cognitive impairment through promoting cortical excitability, modulating neurotransmission, and restoring neuroplasticity. | Device | Intervention Sequence 1, Intervention Sequence 2 |
| Ibogaine Hydrochloride with Magnesium SulfateIbogaine hydrochloride was administered orally. Ibogaine is an indole alkaloid that together with its metabolites interacts with mu opioid, kappa opioid, N-methyl-D-aspartate receptor (NMDA), and nicotinic acetylcholine receptors. Ibogaine has shown early signs of effectiveness as a rapid-acting treatment for a number of mental health disorders including PTSD and substance use disorder. Magnesium sulfate was administered intravenously prior to Ibogaine administration and orally each day. | Drug | Intervention Sequence 1, Intervention Sequence 2 |
| 5-methoxy-N,N-dimethyltryptamine5-MeO-DMT is administered by using a pipe to inhale a vapor that is produced by heating a canister containing a powder form of the substance. 5-MeO-DMT is a 5-HT-1A and 5-HT-2A agonist compound that has shown early signs of effectiveness in treating depression. Inhaled 5-MeO-DMT has a short duration of action, producing an intense, time-limited psychoactive state. | Drug | Intervention Sequence 1, Intervention Sequence 2 |
| Physiological SupplementationPhysiological Supplementation describes a treatment program aimed at restoring healthy endocrine functioning, using supplements such as the following: Synthetic testosterone, Anastrozole, Gonadorelin, Vitamin and amino acid supplementation, Fish oil, Ipamorelin. | Drug | Intervention Sequence 1, Intervention Sequence 2 |
Primary outcome
PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL-5)
Time frame: Up to 12 months follow up
The PTSD Checklist for DSM-5 (PCL-5) is a self-report questionnaire designed to assess the severity of PTSD symptoms in alignment with the DSM-5 diagnostic criteria. A total symptom severity score (range - 0-80) will be obtained by summing the scores for each of the 20 items with higher scores indicating greater symptom severity. Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3 month follow up (MFU), 6MFU, 12MFU.
Medical Outcomes Study Cognitive Functioning Scale (MOS-CF)
Time frame: Up to 12 months follow up
The Medical Outcomes Study - Cognitive Functioning (MOS-CF) self-report scale consists of 6 items that are designed to measure perceived cognitive functioning. Each item is scored on a 6-point scale (1-6), with 1 being 'all of the time' and 6 being 'none of the time.' Higher scores indicate higher cognitive functioning and lower cognitive symptoms. Collected - Group/Sequence 1: Baseline, pre-HRT, pre-MeRT, mid-MeRT (week 3 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group/Sequence 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
Stroop Squared Task
Time frame: Up to 12 months follow-up
In the Stroop Squared Task, participants will select words corresponding to the color of the stimulus word given. For example, participants will name the color of the ink a word is printed in while ignoring the word itself (e.g., the word "BLUE" printed in red ink). The task primarily measures cognitive inhibition. Each participant will receive one score indexing the delay in reaction time caused by the mismatch between word and color. Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3MFU, 6MFU, 12MFU.
Externalized Free Recall with Emotional Words Task
Time frame: Up to 15 weeks (Post-MeRT for Group A, Post-IM/5MeO for Group B)
In the Externalized Free Recall with Emotional Words Task, participants will be presented with a series of emotionally positive, negative, and neutral stimuli (e.g., words or images) and asked to recall the stimuli. The task captures how well individuals retain and recall emotional versus neutral content. Dependent variables include: V1. The proportion of total words correctly recalled of total words administered V1.1. The proportion of recalled negative words of all words recalled V1.2. The proportion of recalled positive words of all words recalled V1.3. The proportion of recalled neutral words of all words recalled V2. The absolute number of total recall intrusions V2.1. The proportion of intruding negative words of all intruding words V2.2. The proportion of intruding positive words of all intruding words V2.3. The proportion of intruding neutral words of all intruding words Data Collected: Group/Sequence A: pre-PS, Post-MeRT; Group/Sequence B: pre-PS, post-IM/5Meo.
2 secondary outcomes
Depressive Symptom Index-Suicidality Subscale (DSI-SS)
Time frame: Up to 12 month follow-up
Adverse Events
Time frame: Up to 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
I S Kroop study director
Axial Therapeutic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD - Post Traumatic Stress Disorder and Cognitive Dysfunction, run by Axial Therapeutic Research 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 14 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL-5) (time frame: Up to 12 months follow up). 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 21 Jul 2026.