PTSDPhase 1/2CONCHKAPNCT06036511

Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD

A Phase 1/2 study testing Ketamine Hydrochloride in people with PTSD, run by University of New Mexico at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to learn about the effects of Ketamine Assisted Psychotherapy [KAP] on individuals with Post Traumatic Stress Disorder [PTSD]. The main questions it aims to answer are: 1. Does KAP improve symptoms of PTSD? 2. What changes in brain network connectivity are seen with KAP? Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: PTSD
What is being tested?: Ketamine Hydrochloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 31 Dec 2023to 31 Dec 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants may be eligible for enrollment if all the following inclusion criteria apply within the thirty days prior to first ketamine administration session:
Between the ages of 18 to 65 years old.
Meet DSM-5 criteria for Port-Traumatic Stress Disorder [PTSD] based on clinical interview.
Able to provide informed consent.
Are proficient in reading and speaking English.
Agree to refrain from using stimulants during the day of the medication session.

Show all 12Show fewer

Agree to refrain from alcohol and cannabis for 24 hours before and the day of medication session.
Subjects taking other psychotropic medications (e.g. anti-depressants, anxiolytics, methadone, buprenorphine, naltrexone) must be maintained on a stable dose for at least four weeks before study initiation.
Agree to not operate a car or any other heavy equipment for the rest of the day after the ketamine administration.
If necessary, are willing to be contacted via telephone on a daily basis by the therapist or team after each experiential session.
Able to identify one or two caregiver support persons who can drive participant home, stay with them overnight, be reached by the team, and provide collateral information as needed.
Willing to inform the investigator within 48 hours if any medical conditions occur or procedures are planned.

Who cannot join

Participants will be excluded from the study if any of the following criteria apply:
They are considered an immediate suicide risk by clinician assessment or felt to be likely to require hospitalization during the study.
Have had a psychiatric or medical hospitalization, or an Emergency Department visit, within four weeks of the study entry.
Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview.
Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview.
Subjects meeting DSM-5 criteria for current substance use disorder (i.e., not in early or sustained remission) other than tobacco use disorder.

Show all 15Show fewer

Subjects who report use of ketamine >20 times in the past or who meet DSM-5 criteria for Other Hallucinogen Use Disorder due to ketamine use including subjects who are currently in early or sustained remission.
Women who are pregnant or nursing, and women who do not consent to use methods of highly effective birth control during the study.
Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) >140 mmHg or a diastolic blood pressure (DBP) >90 mmHg.
A history of allergic or other adverse reaction to ketamine (or its excipients).
Clinically significant physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, aneurysmal disease, cardiovascular disease, or end-stage renal disease).
QTc will be measured in all subjects and those with QTc 450ms or longer will be excluded.
High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).
Documented evidence of significant renal or hepatic dysfunction at screening. Significantly impaired liver function is defined as 1) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN); 2) ALT or AST > 3 × ULN with concomitant total bilirubin > 2.0 × ULN; or 3) ALT or AST ≥ 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia.
Blood pressure will be monitored at all subsequent visits, and participants will receive study medication only if blood pressure is less than or equal to 140 systolic, 90 diastolic at safety screening on the day of the drug administration sessions.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of New Mexico
Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Does KAP improve symptoms of PTSD?
What changes in brain network connectivity are seen with KAP?

Read the detailed description

A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.

Conditions: PTSD
Being tested: Ketamine Hydrochloride
Keywords: PTSD, Ketamine Assisted Psychotherapy, Brain network connectivity
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketamine HydrochlorideDrug
Also called KAP
This is a single arm, open-label, prospective cohort clinical trial.
No blinding is required for this trial.
A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.

Study groups in NCT06036511
Study group	Role	What they receive
Ketamine Assisted Psychotherapy [KAP]	Experimental	A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI. Receives: Drug: Ketamine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical outcome: PTSD severity
as defined by change in score on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) following KAP treatments (Assessment Visit 3) compared to baseline (Assessment Visit 1).
Measured: 14-21 days
Imaging Outcome: Changes in functional connectivity
change in the functional connectivity between vmPFC and amygdala from Baseline to Assessment Visit 4 as measured by fMRI.
Measured: 28-35 days

Secondary outcomes (4)

Depression severity
Improvement in depression, as indicated by reduced Montgomery-Asberg Depression Rating Scale (MADRS), following KAP treatments (Assessment Visit 3) compared to baseline (Assessment Visit 1).
Measured: 14-21 days
Persisting PTSD effect
The changes in score on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
Measured: 28-35 days
Correlation of clinical and imaging outcomes
Change in connectivity between the vmPFC and amygdala from Assessment Visit 1 to Assessment Visit 4 with degree of PTSD symptom change.
Measured: 28-35 days
Persisting MDD effect
Concurrent MDD (MADRS) will persist at last evaluation two weeks after completion of active treatment.
Measured: 28-35 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 202331 Dec 2023

First posted14 Sep 2023
Study start31 Dec 2023
Primary completion31 Dec 2023
Study completion31 Dec 2023

Why it stopped: Per PI, this trial will not be started at UNM due to change in institutional responsibilities of the PI

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single arm, open-label, prospective cohort clinical trial. No blinding is required for this trial. A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06036511
Sponsor's protocol ID: 23-116
Acronym: CONCHKAP
Status last verified: Mar 2024
First submitted: 3 Aug 2023
Last updated: 12 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Drozdz SJ, Goel A, McGarr MW, Katz J, Ritvo P, Mattina GF, Bhat V, Diep C, Ladha KS. Ketamine Assisted Psychotherapy: A Systematic Narrative Review of the Literature. J Pain Res. 2022 Jun 15;15:1691-1706. doi: 10.2147/JPR.S360733. eCollection 2022.
PubMed 35734507
Joneborg I, Lee Y, Di Vincenzo JD, Ceban F, Meshkat S, Lui LMW, Fancy F, Rosenblat JD, McIntyre RS. Active mechanisms of ketamine-assisted psychotherapy: A systematic review. J Affect Disord. 2022 Oct 15;315:105-112. doi: 10.1016/j.jad.2022.07.030. Epub 2022 Jul 26.
PubMed 35905796
Dore J, Turnipseed B, Dwyer S, Turnipseed A, Andries J, Ascani G, Monnette C, Huidekoper A, Strauss N, Wolfson P. Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy. J Psychoactive Drugs. 2019 Apr-Jun;51(2):189-198. doi: 10.1080/02791072.2019.1587556. Epub 2019 Mar 27.
PubMed 30917760
Feder A, Costi S, Rutter SB, Collins AB, Govindarajulu U, Jha MK, Horn SR, Kautz M, Corniquel M, Collins KA, Bevilacqua L, Glasgow AM, Brallier J, Pietrzak RH, Murrough JW, Charney DS. A Randomized Controlled Trial of Repeated Ketamine Administration for Chronic Posttraumatic Stress Disorder. Am J Psychiatry. 2021 Feb 1;178(2):193-202. doi: 10.1176/appi.ajp.2020.20050596. Epub 2021 Jan 5.
PubMed 33397139
Ionescu DF, Felicione JM, Gosai A, Cusin C, Shin P, Shapero BG, Deckersbach T. Ketamine-Associated Brain Changes: A Review of the Neuroimaging Literature. Harv Rev Psychiatry. 2018 Nov/Dec;26(6):320-339. doi: 10.1097/HRP.0000000000000179.
PubMed 29465479
Norbury A, Rutter SB, Collins AB, Costi S, Jha MK, Horn SR, Kautz M, Corniquel M, Collins KA, Glasgow AM, Brallier J, Shin LM, Charney DS, Murrough JW, Feder A. Neuroimaging correlates and predictors of response to repeated-dose intravenous ketamine in PTSD: preliminary evidence. Neuropsychopharmacology. 2021 Dec;46(13):2266-2277. doi: 10.1038/s41386-021-01104-4. Epub 2021 Jul 31.
PubMed 34333555
Krystal JH, Abdallah CG, Averill LA, Kelmendi B, Harpaz-Rotem I, Sanacora G, Southwick SM, Duman RS. Synaptic Loss and the Pathophysiology of PTSD: Implications for Ketamine as a Prototype Novel Therapeutic. Curr Psychiatry Rep. 2017 Aug 26;19(10):74. doi: 10.1007/s11920-017-0829-z.
PubMed 28844076
Patel R, Spreng RN, Shin LM, Girard TA. Neurocircuitry models of posttraumatic stress disorder and beyond: a meta-analysis of functional neuroimaging studies. Neurosci Biobehav Rev. 2012 Oct;36(9):2130-42. doi: 10.1016/j.neubiorev.2012.06.003. Epub 2012 Jul 2.
PubMed 22766141
Sheynin J, Liberzon I. Circuit dysregulation and circuit-based treatments in posttraumatic stress disorder. Neurosci Lett. 2017 May 10;649:133-138. doi: 10.1016/j.neulet.2016.11.014. Epub 2016 Nov 12.
PubMed 27845239
Stopyra MA, Simon JJ, Rheude C, Nikendei C. Pathophysiological aspects of complex PTSD - a neurobiological account in comparison to classic posttraumatic stress disorder and borderline personality disorder. Rev Neurosci. 2022 Aug 8;34(1):103-128. doi: 10.1515/revneuro-2022-0014. Print 2023 Jan 27.
PubMed 35938987
Fonzo GA, Goodkind MS, Oathes DJ, Zaiko YV, Harvey M, Peng KK, Weiss ME, Thompson AL, Zack SE, Lindley SE, Arnow BA, Jo B, Rothbaum BO, Etkin A. Amygdala and Insula Connectivity Changes Following Psychotherapy for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Biol Psychiatry. 2021 May 1;89(9):857-867. doi: 10.1016/j.biopsych.2020.11.021. Epub 2020 Dec 8.
PubMed 33516458

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD
ClinicalTrials.gov ID: NCT06036511
Acronym / sponsor ID: CONCHKAP / 23-116
Conditions: PTSD
Keywords: PTSD, Ketamine Assisted Psychotherapy, Brain network connectivity
Phase: Phase 1/2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Per PI, this trial will not be started at UNM due to change in institutional responsibilities of the PI
Enrolment: 0 participants (actual)
Lead sponsor: University of New MexicoUniversity, hospital or other
Collaborators: The Mind Research Network
Study start: 31 Dec 2023 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 14 Sep 2023 (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.

Does KAP improve symptoms of PTSD?
What changes in brain network connectivity are seen with KAP?

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single arm, open-label, prospective cohort clinical trial. No blinding is required for this trial. A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.

Arm	Type	Receives
Ketamine Assisted Psychotherapy [KAP]	Experimental	Drug: Ketamine HydrochlorideA total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Participants may be eligible for enrollment if all the following inclusion criteria apply within the thirty days prior to first ketamine administration session:
Between the ages of 18 to 65 years old.
Meet DSM-5 criteria for Port-Traumatic Stress Disorder [PTSD] based on clinical interview.
Able to provide informed consent.
Are proficient in reading and speaking English.

Key exclusion criteria (15 listed)

Participants will be excluded from the study if any of the following criteria apply:
They are considered an immediate suicide risk by clinician assessment or felt to be likely to require hospitalization during the study.
Have had a psychiatric or medical hospitalization, or an Emergency Department visit, within four weeks of the study entry.
Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview.
Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview.

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
Ketamine HydrochlorideAlso: KAPThis is a single arm, open-label, prospective cohort clinical trial. No blinding is required for this trial. A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.	Drug	Ketamine Assisted Psychotherapy [KAP]

Primary outcome

Clinical outcome: PTSD severity
Time frame: 14-21 days
as defined by change in score on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) following KAP treatments (Assessment Visit 3) compared to baseline (Assessment Visit 1).
Imaging Outcome: Changes in functional connectivity
Time frame: 28-35 days
change in the functional connectivity between vmPFC and amygdala from Baseline to Assessment Visit 4 as measured by fMRI.

4 secondary outcomes

Depression severity
Time frame: 14-21 days
Persisting PTSD effect
Time frame: 28-35 days
Correlation of clinical and imaging outcomes
Time frame: 28-35 days
Persisting MDD effect
Time frame: 28-35 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Background: PubMed 35734507Drozdz SJ, Goel A, McGarr MW, Katz J, Ritvo P, Mattina GF, Bhat V, Diep C, Ladha KS. Ketamine Assisted Psychotherapy: A Systematic Narrative Review of the Literature. J Pain Res. 2022 Jun 15;15:1691-1706. doi: 10.2147/JPR.S360733. eCollection 2022.
Background: PubMed 35905796Joneborg I, Lee Y, Di Vincenzo JD, Ceban F, Meshkat S, Lui LMW, Fancy F, Rosenblat JD, McIntyre RS. Active mechanisms of ketamine-assisted psychotherapy: A systematic review. J Affect Disord. 2022 Oct 15;315:105-112. doi: 10.1016/j.jad.2022.07.030. Epub 2022 Jul 26.
Background: PubMed 30917760Dore J, Turnipseed B, Dwyer S, Turnipseed A, Andries J, Ascani G, Monnette C, Huidekoper A, Strauss N, Wolfson P. Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy. J Psychoactive Drugs. 2019 Apr-Jun;51(2):189-198. doi: 10.1080/02791072.2019.1587556. Epub 2019 Mar 27.
Background: PubMed 33397139Feder A, Costi S, Rutter SB, Collins AB, Govindarajulu U, Jha MK, Horn SR, Kautz M, Corniquel M, Collins KA, Bevilacqua L, Glasgow AM, Brallier J, Pietrzak RH, Murrough JW, Charney DS. A Randomized Controlled Trial of Repeated Ketamine Administration for Chronic Posttraumatic Stress Disorder. Am J Psychiatry. 2021 Feb 1;178(2):193-202. doi: 10.1176/appi.ajp.2020.20050596. Epub 2021 Jan 5.
Background: PubMed 29465479Ionescu DF, Felicione JM, Gosai A, Cusin C, Shin P, Shapero BG, Deckersbach T. Ketamine-Associated Brain Changes: A Review of the Neuroimaging Literature. Harv Rev Psychiatry. 2018 Nov/Dec;26(6):320-339. doi: 10.1097/HRP.0000000000000179.
Background: PubMed 34333555Norbury A, Rutter SB, Collins AB, Costi S, Jha MK, Horn SR, Kautz M, Corniquel M, Collins KA, Glasgow AM, Brallier J, Shin LM, Charney DS, Murrough JW, Feder A. Neuroimaging correlates and predictors of response to repeated-dose intravenous ketamine in PTSD: preliminary evidence. Neuropsychopharmacology. 2021 Dec;46(13):2266-2277. doi: 10.1038/s41386-021-01104-4. Epub 2021 Jul 31.
Background: PubMed 28844076Krystal JH, Abdallah CG, Averill LA, Kelmendi B, Harpaz-Rotem I, Sanacora G, Southwick SM, Duman RS. Synaptic Loss and the Pathophysiology of PTSD: Implications for Ketamine as a Prototype Novel Therapeutic. Curr Psychiatry Rep. 2017 Aug 26;19(10):74. doi: 10.1007/s11920-017-0829-z.
Background: PubMed 22766141Patel R, Spreng RN, Shin LM, Girard TA. Neurocircuitry models of posttraumatic stress disorder and beyond: a meta-analysis of functional neuroimaging studies. Neurosci Biobehav Rev. 2012 Oct;36(9):2130-42. doi: 10.1016/j.neubiorev.2012.06.003. Epub 2012 Jul 2.
Background: PubMed 27845239Sheynin J, Liberzon I. Circuit dysregulation and circuit-based treatments in posttraumatic stress disorder. Neurosci Lett. 2017 May 10;649:133-138. doi: 10.1016/j.neulet.2016.11.014. Epub 2016 Nov 12.
Background: PubMed 35938987Stopyra MA, Simon JJ, Rheude C, Nikendei C. Pathophysiological aspects of complex PTSD - a neurobiological account in comparison to classic posttraumatic stress disorder and borderline personality disorder. Rev Neurosci. 2022 Aug 8;34(1):103-128. doi: 10.1515/revneuro-2022-0014. Print 2023 Jan 27.
Background: PubMed 33516458Fonzo GA, Goodkind MS, Oathes DJ, Zaiko YV, Harvey M, Peng KK, Weiss ME, Thompson AL, Zack SE, Lindley SE, Arnow BA, Jo B, Rothbaum BO, Etkin A. Amygdala and Insula Connectivity Changes Following Psychotherapy for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Biol Psychiatry. 2021 May 1;89(9):857-867. doi: 10.1016/j.biopsych.2020.11.021. Epub 2020 Dec 8.
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.

Snehal Bhatt, MD principal investigator

UNM

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ketamine Hydrochloride in people with PTSD, run by University of New Mexico 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 12 inclusion and 15 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: withdrawn, as of the sponsor's last update on 12 Mar 2024. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Clinical outcome: PTSD severity (time frame: 14-21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06036511, which also lists 11 linked publications.

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 12 Mar 2024.