Major Depressive DisorderKetGDNCT05565352

Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

An observational study of Major Depressive Disorder and Post Traumatic Stress Disorder, run by Medical University of Gdansk at 1 site in Poland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Major Depressive Disorder, Post Traumatic Stress Disorder, Obsessive-Compulsive Disorder
What is being tested?: Ketamine Hydrochloride
Type of treatment: Pill or oral medicine, Injection or infusion
How many people: 140 participants
Where: 1 sitePoland
Study dates: 1 Sep 2022to 31 Dec 2029
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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Inpatients are referred to the tertiary-reference unit for mood disorders, anxiety disorders, obsessive-compulsive disorder, somatoform disorder, post-traumatic stress disorder, and dissociative disorder

Who may be able to join

Diagnosis as provided by DSM-5 criteria:
Major depressive disorder (MDD),
Bipolar disorder (BD),
Anxiety disorder,
Obsessive-compulsive disorder (OCD),
Somatoform disorder,
Post-traumatic stress disorder (PTSD),
Dissociative disorder

Who cannot join

Pregnancy and lactation
Hypersensitivity to ketamine
Uncontrolled hypertension
Other uncontrolled somatic diseases that may impact safety per the investigator's judgment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Poland1 site

Department of Psychiatry, Medical University of Gdańsk
Gdansk, 80-952

Other trials in Poland

About this study

Official title: Ketamine Treatment Safety and Tolerability in Psychiatric Inpatient Care Delivered at Depatment of Psychiatry, Medical University of Gdańsk, Poland

This observational registry aims to collect real-world data on ketamine use in psychiatric inpatients within a regional tertiary-reference center. The study evaluates the safety and tolerability of ketamine administration in individuals with treatment-resistant mental disorders, characterized by diverse comorbidities, heterogeneous disease courses, and variations in treatment responses based on illness stage and severity with a subset of patients with remitted-recurrent and treatment-resistant or chronic presentations.

The registry is designed to systematically document adverse events, side effects, and patient-reported outcomes, providing a comprehensive assessment of both the short- and long-term effects of ketamine in psychopharmacology. By generating real-world evidence, this study shall contribute to a more nuanced understanding of ketamine's risk-benefit profile in clinical practice, particularly in subpopulations that are underrepresented in clinical trials. The findings prioritize the support for the refinement of treatment protocols and enhance patient safety in psychiatric care.

Conditions: Major Depressive Disorder, Post Traumatic Stress Disorder, Obsessive-Compulsive Disorder, Somatoform Disorders, Anxiety Disorders, Dissociative Disorder
Being tested: Ketamine Hydrochloride
Medical subject headings: Depressive Disorder, Major, Stress Disorders, Post-Traumatic, Obsessive-Compulsive Disorder, Somatoform Disorders, Anxiety Disorders, Dissociative Disorders

What participants receive

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

Ketamine HydrochlorideDrug
Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks) Ketamine will be given in intranasal spray twice weekly over a period of 4 weeks Ketamine will be given orally (solution 2.0mg/kg, 2.5mg/kg) twice weekly over a period of 4 weeks.

Study groups in NCT05565352
Study group	Role	What they receive
Major Depressive Disorder		Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD), as determined by a psychiatrist. Receives: Drug: Ketamine Hydrochloride
Obsessive Compulsive Disorder		Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Obsessive Compulsive Disorder (OCD) as determined by a psychiatrist. Receives: Drug: Ketamine Hydrochloride
Post traumatic Stress Disorder		Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Post-Traumatic Stress Disorder (PTSD) as determined by a psychiatrist. Receives: Drug: Ketamine Hydrochloride
Somatoform Disorder		Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Somatoform Disorder as determined by a psychiatrist. Receives: Drug: Ketamine Hydrochloride
Anxiety Disorder		Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Anxiety Disorder as determined by a psychiatrist. Receives: Drug: Ketamine Hydrochloride
Dissociative Disorder		Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Dissociative Disorder as determined by a psychiatrist. Receives: Drug: Ketamine Hydrochloride
Bipolar Disorder		Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Bipolar Disorder as determined by a psychiatrist. Receives: Drug: Ketamine Hydrochloride

What is being measured

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

Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS)
Incidence of adverse events will be assessed by Clinician-Administered Dissociative Symptoms Scale (change from baseline to each measure). Higher values represent a worse severity, but not necessarily outcome. The Clinical-Administered Dissociative Symptoms Scale has 23-items based on dissociative symptoms during the assessment. Each item is scored 0 (normal) to 4 (severe symptoms) with overall score ranges from 0 (normal) to 92 (severe symptoms). Total number of assessments:18 times
Measured: Baseline through week 5
Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS)
Incidence of adverse events will be assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (change from baseline to each measure). Higher values represent a worse severity but not necessarily outcome. The 4-item positive symptoms subscale of Brief Psychiatric Rating Scale has 4-items based on conceptual disorganization, suspiciousness, hallucination and unusual thought content. Each item is scored 0 (normal) to 6 (severe symptoms) with overall score ranges from 0 (normal) to 24 (severe symptoms).
Measured: Baseline through week 5
Incidence of adverse events assessed by body temperature (oral measurements)
Incidence of adverse events assessed by body temperature (oral measurement) in Celsius degree - change from baseline to each measure. A normal range is from 36.2 to 38.0 Celsius degrees; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times
Measured: Baseline through week 5
Incidence of adverse events assessed by blood pressure
Incidence of adverse events assessed by blood pressure (after the participant has rested for at least 5 minutes) in mmHg - change from baseline to each measure. A normal range for systolic blood pressure is from 90 to 140 mmHg, for diastolic blood pressure is from 50 to 90 mmHg; measurements beyond those ranges are clinically significant.
Measured: Baseline through week 5
Incidence of adverse events assessed by respiration rate
Incidence of adverse events assessed by respiration rate in a breath number per minute - change from baseline to each measure. A normal range for respiration is from 12 to 16 breaths per minute; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times
Measured: Baseline through week 5
Incidence of adverse events assessed by pulse
Incidence of adverse events assessed by pulse (beats per minute [bpm]) - change from baseline to each measure. A normal range for pulse is from 60 to 90 bpm; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times
Measured: Baseline through week 5
Incidence of adverse events assessed by blood oxygen saturation
Incidence of adverse events assessed by blood oxygen saturation in percentage - change from baseline to each measure. A normal range for blood oxygen saturation is from 95 to 100 percentage; measurements under 95% are clinically significant. The total number of measurements: 44 times
Measured: Baseline through week 5
Incidence of adverse events assessed by weight
Incidence of adverse events assessed by weight in kilograms- change from baseline to each measure. Gain weight for 7% baseline weight is clinically significant. Total numbers of assessments: 2. Weight and height will be combined to report BMI in kg/m^2
Measured: Baseline through week 5

Secondary outcomes (5)

Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
Change in severity of depression symptoms from baseline to each measure. Higher values represent a worse severity, but not necessarily outcome. The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each item is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
Measured: Baseline through week 5
Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S)
CGI-S is a seven-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. CGI-S score starting from 1-not at all ending at 7-extremely severe.
Measured: Baseline through week 5
Change in severity of symptoms assessed by Clinical Global Impression - Improvement Scale (CGI-I)
CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.CGI-I score starting from 1-very much-improved ending at 7-very much worse
Measured: Baseline through week 5
Change in severity of symptoms assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is an assessment tool that evaluates suicidal ideation and behavior.
Measured: Baseline through week 5
Change in severity of mania symptoms assessed by Young Mania Rating Scale (YMRS)
YMRS is an 11-item interviewer-rated scale used to evaluate manic symptoms at baseline and over time. The total scale score ranges from 0 to 60, where higher scores indicate more severe mania.
Measured: Baseline through week 5

Timeline

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

1 Sep 202231 Dec 2029

First posted4 Oct 2022
Study start1 Sep 2022
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Medical University of GdanskThe sponsor's other registered studies.
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: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05565352
Sponsor's protocol ID: NKBBN/172-447/2022
Acronym: KetGD
Status last verified: Mar 2025
First submitted: 29 Sep 2022
Last updated: 2 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Wilkowska A, Wiglusz MS, Galuszko-Wegielnik M, Wlodarczyk A, Cubala WJ. Antianhedonic Effect of Repeated Ketamine Infusions in Patients With Treatment Resistant Depression. Front Psychiatry. 2021 Oct 18;12:704330. doi: 10.3389/fpsyt.2021.704330. eCollection 2021.
PubMed 34733182
Wilkowska A, Wlodarczyk A, Galuszko-Wegielnik M, Wiglusz MS, Cubala WJ. Intravenous Ketamine Infusions in Treatment-Resistant Bipolar Depression: An Open-Label Naturalistic Observational Study. Neuropsychiatr Dis Treat. 2021 Aug 14;17:2637-2646. doi: 10.2147/NDT.S325000. eCollection 2021.
PubMed 34421299
Wlodarczyk A, Cubala WJ, Galuszko-Wegielnik M, Szarmach J. Central nervous system-related safety and tolerability of add-on ketamine to antidepressant medication in treatment-resistant depression: focus on the unique safety profile of bipolar depression. Ther Adv Psychopharmacol. 2021 May 19;11:20451253211011021. doi: 10.1177/20451253211011021. eCollection 2021.
PubMed 34046159
Kachlik Z, Cubala WJ, Walaszek M, Pastuszak M, Pastuszak K, Kwasny A. Nonresponse to Ketamine in Treatment-Resistant Bipolar Depression. Neuropsychopharmacol Rep. 2025 Sep;45(3):e70038. doi: 10.1002/npr2.70038.
PubMed 40879542

Interested in taking part?

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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ketamine Treatment Safety and Tolerability in Psychiatric Inpatient Care Delivered at Depatment of Psychiatry, Medical University of Gdańsk, Poland
ClinicalTrials.gov ID: NCT05565352
Acronym / sponsor ID: KetGD / NKBBN/172-447/2022
Conditions: Major Depressive Disorder, Post Traumatic Stress Disorder, Obsessive-Compulsive Disorder, Somatoform Disorders, Anxiety Disorders, Dissociative Disorder
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 140 participants (estimated)
Lead sponsor: Medical University of GdanskUniversity, hospital or other
Study start: 1 Sep 2022 (actual)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 4 Oct 2022 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 7

Arm	Type	Receives
Major Depressive Disorder	–	Drug: Ketamine HydrochloridePatients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD), as determined by a psychiatrist.
Obsessive Compulsive Disorder	–	Drug: Ketamine HydrochloridePatients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Obsessive Compulsive Disorder (OCD) as determined by a psychiatrist.
Post traumatic Stress Disorder	–	Drug: Ketamine HydrochloridePatients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Post-Traumatic Stress Disorder (PTSD) as determined by a psychiatrist.
Somatoform Disorder	–	Drug: Ketamine HydrochloridePatients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Somatoform Disorder as determined by a psychiatrist.
Anxiety Disorder	–	Drug: Ketamine HydrochloridePatients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Anxiety Disorder as determined by a psychiatrist.
Dissociative Disorder	–	Drug: Ketamine HydrochloridePatients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Dissociative Disorder as determined by a psychiatrist.
Bipolar Disorder	–	Drug: Ketamine HydrochloridePatients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Bipolar Disorder as determined by a psychiatrist.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Inpatients are referred to the tertiary-reference unit for mood disorders, anxiety disorders, obsessive-compulsive disorder, somatoform disorder, post-traumatic stress disorder, and dissociative disorder

Key inclusion criteria (8 listed)

Major depressive disorder (MDD),
Bipolar disorder (BD),
Anxiety disorder,
Obsessive-compulsive disorder (OCD),
Somatoform disorder,

Key exclusion criteria (4 listed)

Pregnancy and lactation
Hypersensitivity to ketamine
Uncontrolled hypertension
Other uncontrolled somatic diseases that may impact safety per the investigator's judgment

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 HydrochlorideKetamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks) Ketamine will be given in intranasal spray twice weekly over a period of 4 weeks Ketamine will be given orally (solution 2.0mg/kg, 2.5mg/kg) twice weekly over a period of 4 weeks.	Drug	Anxiety Disorder, Bipolar Disorder, Dissociative Disorder, Major Depressive Disorder, Obsessive Compulsive Disorder, Post traumatic Stress Disorder, Somatoform Disorder

Primary outcome

Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS)
Time frame: Baseline through week 5
Incidence of adverse events will be assessed by Clinician-Administered Dissociative Symptoms Scale (change from baseline to each measure). Higher values represent a worse severity, but not necessarily outcome. The Clinical-Administered Dissociative Symptoms Scale has 23-items based on dissociative symptoms during the assessment. Each item is scored 0 (normal) to 4 (severe symptoms) with overall score ranges from 0 (normal) to 92 (severe symptoms). Total number of assessments:18 times
Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline through week 5
Incidence of adverse events will be assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (change from baseline to each measure). Higher values represent a worse severity but not necessarily outcome. The 4-item positive symptoms subscale of Brief Psychiatric Rating Scale has 4-items based on conceptual disorganization, suspiciousness, hallucination and unusual thought content. Each item is scored 0 (normal) to 6 (severe symptoms) with overall score ranges from 0 (normal) to 24 (severe symptoms).
Incidence of adverse events assessed by body temperature (oral measurements)
Time frame: Baseline through week 5
Incidence of adverse events assessed by body temperature (oral measurement) in Celsius degree - change from baseline to each measure. A normal range is from 36.2 to 38.0 Celsius degrees; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times
Incidence of adverse events assessed by blood pressure
Time frame: Baseline through week 5
Incidence of adverse events assessed by blood pressure (after the participant has rested for at least 5 minutes) in mmHg - change from baseline to each measure. A normal range for systolic blood pressure is from 90 to 140 mmHg, for diastolic blood pressure is from 50 to 90 mmHg; measurements beyond those ranges are clinically significant.
Incidence of adverse events assessed by respiration rate
Time frame: Baseline through week 5
Incidence of adverse events assessed by respiration rate in a breath number per minute - change from baseline to each measure. A normal range for respiration is from 12 to 16 breaths per minute; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times
Incidence of adverse events assessed by pulse
Time frame: Baseline through week 5
Incidence of adverse events assessed by pulse (beats per minute [bpm]) - change from baseline to each measure. A normal range for pulse is from 60 to 90 bpm; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times
Incidence of adverse events assessed by blood oxygen saturation
Time frame: Baseline through week 5
Incidence of adverse events assessed by blood oxygen saturation in percentage - change from baseline to each measure. A normal range for blood oxygen saturation is from 95 to 100 percentage; measurements under 95% are clinically significant. The total number of measurements: 44 times
Incidence of adverse events assessed by weight
Time frame: Baseline through week 5
Incidence of adverse events assessed by weight in kilograms- change from baseline to each measure. Gain weight for 7% baseline weight is clinically significant. Total numbers of assessments: 2. Weight and height will be combined to report BMI in kg/m^2

5 secondary outcomes

Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline through week 5
Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S)
Time frame: Baseline through week 5
Change in severity of symptoms assessed by Clinical Global Impression - Improvement Scale (CGI-I)
Time frame: Baseline through week 5
Change in severity of symptoms assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline through week 5
Change in severity of mania symptoms assessed by Young Mania Rating Scale (YMRS)
Time frame: Baseline through week 5

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 2 Apr 2025.
Background: PubMed 34733182Wilkowska A, Wiglusz MS, Galuszko-Wegielnik M, Wlodarczyk A, Cubala WJ. Antianhedonic Effect of Repeated Ketamine Infusions in Patients With Treatment Resistant Depression. Front Psychiatry. 2021 Oct 18;12:704330. doi: 10.3389/fpsyt.2021.704330. eCollection 2021.
Background: PubMed 34421299Wilkowska A, Wlodarczyk A, Galuszko-Wegielnik M, Wiglusz MS, Cubala WJ. Intravenous Ketamine Infusions in Treatment-Resistant Bipolar Depression: An Open-Label Naturalistic Observational Study. Neuropsychiatr Dis Treat. 2021 Aug 14;17:2637-2646. doi: 10.2147/NDT.S325000. eCollection 2021.
Background: PubMed 34046159Wlodarczyk A, Cubala WJ, Galuszko-Wegielnik M, Szarmach J. Central nervous system-related safety and tolerability of add-on ketamine to antidepressant medication in treatment-resistant depression: focus on the unique safety profile of bipolar depression. Ther Adv Psychopharmacol. 2021 May 19;11:20451253211011021. doi: 10.1177/20451253211011021. eCollection 2021.
Derived from this study: PubMed 40879542Kachlik Z, Cubala WJ, Walaszek M, Pastuszak M, Pastuszak K, Kwasny A. Nonresponse to Ketamine in Treatment-Resistant Bipolar Depression. Neuropsychopharmacol Rep. 2025 Sep;45(3):e70038. doi: 10.1002/npr2.70038.
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.

The record lists no contact. Use the official record to reach the sponsor.

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 Major Depressive Disorder and Post Traumatic Stress Disorder, run by Medical University of Gdansk at 1 site in Poland.

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 8 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 2 Apr 2025. 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 Poland. 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?

Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS) (time frame: Baseline through week 5). The study lists 8 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 NCT05565352, which also lists 4 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 2 Apr 2025.