HealthyPhase 1NCT04602221

A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine

A Phase 1 study testing Lamotrigine, BI 409306 and BI 425809 in people with Healthy, run by Boehringer Ingelheim at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits. Read more about this study

Who is it for?: Ages 18 to 55 years, men only
Conditions the study is for: Healthy
What is being tested?: Lamotrigine, BI 409306 and BI 425809
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: 1 Dec 2020to 12 Aug 2022
Phase: Phase 1
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 18 to 55 years
Men only
No healthy volunteers
Adult

Who may be able to join

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 55 years (inclusive)
BMI of 18.5 to 32 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Use of adequate contraception, e.g. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide)

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Sexually abstinent
Vasectomised (vasectomy at least 1 year prior to enrolment)
Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy)
Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea

Who cannot join

Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
History of diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Collaborative Neuroscience Research, LLC
Long Beach, California, 90806
Hassman Research Institute
Marlton, New Jersey, 08053

Other trials in United States

About this study

Official title: A Randomized, Placebo Controlled, Double-blind, Double-dummy Three-way Cross Over Trial to Investigate the Effect of BI 409306, BI 425809 and Lamotrigine on Ketamine-induced Cognitive Deficits in Healthy Male Subjects

The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits.

Conditions: Healthy
Being tested: Lamotrigine, BI 409306, Placebo, BI 425809

What participants receive

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

LamotrigineDrug
Tablet
BI 409306Drug
Film-coated tablet
PlaceboDrug
Tablet, Film-coated tablet
BI 425809Drug
Film-coated tablet

Study groups in NCT04602221
Study group	Role	What they receive
Treatment sequence: T1-T2-R	Experimental	Treatments: T1: Lamotrigine T2: BI 409306 T3: BI 425809 R: Placebo Receives: Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo
Treatment sequence: T1-R-T2	Experimental	Not described Receives: Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo
Treatment sequence: T1-T3-R	Experimental	Not described Receives: Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809
Treatment sequence: T1-R-T3	Experimental	Not described Receives: Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809
Treatment sequence: T2-T1-R	Experimental	Not described Receives: Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo
Treatment sequence: T2-R-T1	Experimental	Not described Receives: Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo
Treatment sequence: T2-T3-R	Experimental	Not described Receives: Drug: BI 409306; Drug: Placebo; Drug: BI 425809
Treatment sequence: T2-R-T3	Experimental	Not described Receives: Drug: BI 409306; Drug: Placebo; Drug: BI 425809
Treatment sequence: T3-R-T1	Experimental	Not described Receives: Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809
Treatment sequence: T3-T1-R	Experimental	Not described Receives: Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809
Treatment sequence: T3-T2-R	Experimental	Not described Receives: Drug: BI 409306; Drug: Placebo; Drug: BI 425809
Treatment sequence: T3-R-T2	Experimental	Not described Receives: Drug: BI 409306; Drug: Placebo; Drug: BI 425809
Treatment sequence: R-T1-T2	Experimental	Not described Receives: Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo
Treatment sequence: R-T2-T1	Experimental	Not described Receives: Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo
Treatment sequence: R-T1-T3	Experimental	Not described Receives: Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809
Treatment sequence: R-T3-T1	Experimental	Not described Receives: Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809
Treatment sequence: R-T2-T3	Experimental	Not described Receives: Drug: BI 409306; Drug: Placebo; Drug: BI 425809
Treatment sequence: R-T3-T2	Experimental	Not described Receives: Drug: BI 409306; Drug: Placebo; Drug: BI 425809

What is being measured

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

Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine
Paired Associate Learning (PAL) assesses visual memory and new learning. Boxes are displayed on the screen and open in turn to reveal a number of patterns. Participants are instructed to try to remember the location in which each pattern was shown. After all the boxes have been opened, each pattern is then shown in the center of the screen in a randomised order, and the participant touches the box in which the pattern was located. If an error is made, all the patterns are re-presented to remind the participant of their locations.
The PALTEA28 evaluates the number of errors committed by the subject plus an adjustment for the estimated number of errors they would have made on any stages that were not reached. Calculated across all assessed two, four, six and eight box trials.
Measured: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.

Secondary outcomes (2)

Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine
SWM assesses the ability of the participant to retain spatial information and manipulate it in working memory. A number of coloured boxes are presented on the screen, and the computer hides a token in these boxes one at a time. The participant is instructed to touch the boxes in turn to search for the token that has been hidden. The key task instruction is that the computer will never hide a token in the same coloured box twice in the same problem.
The SWMBE468 evaluates the number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across all assessed four, six and eight token trials.
Measured: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
Rapid Visual Information Processing A' Prime (RVPA) on Ketamine
Rapid Visual Information Processing (RVP) is a sensitive measure of sustained attention, outputting measures of response accuracy, target sensitivity and reaction times.
The RVPA is a quantitative measure for a subject's sensitivity to the target sequence regardless of response tendency. The RVPA ranges from 0.00 to 1.00. The higher the RVPA value, the better the sensitivity to the target sequence one has.
Measured: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.

Timeline

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

1 Dec 202012 Aug 2022

First posted26 Oct 2020
Study start1 Dec 2020
Primary completion1 Aug 2022
Study completion12 Aug 2022

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 HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 3-treatment period design
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04602221
Sponsor's protocol ID: 1289-0057
Status last verified: Aug 2023
First submitted: 16 Oct 2020
Last updated: 12 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

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?

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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: A Randomized, Placebo Controlled, Double-blind, Double-dummy Three-way Cross Over Trial to Investigate the Effect of BI 409306, BI 425809 and Lamotrigine on Ketamine-induced Cognitive Deficits in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04602221
Acronym / sponsor ID: 1289-0057
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Dec 2020 (actual)
Primary completion: 1 Aug 2022 (actual)
Study completion: 12 Aug 2022 (actual)
First posted: 26 Oct 2020 (actual)
Results: Posted 12 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 18
Model description: 3-treatment period design

Arm	Type	Receives
Treatment sequence: T1-T2-R	Experimental	Drug: Lamotrigine, Drug: BI 409306, Drug: PlaceboTreatments: T1: Lamotrigine T2: BI 409306 T3: BI 425809 R: Placebo
Treatment sequence: T1-R-T2	Experimental	Drug: Lamotrigine, Drug: BI 409306, Drug: Placebo
Treatment sequence: T1-T3-R	Experimental	Drug: Lamotrigine, Drug: Placebo, Drug: BI 425809
Treatment sequence: T1-R-T3	Experimental	Drug: Lamotrigine, Drug: Placebo, Drug: BI 425809
Treatment sequence: T2-T1-R	Experimental	Drug: Lamotrigine, Drug: BI 409306, Drug: Placebo
Treatment sequence: T2-R-T1	Experimental	Drug: Lamotrigine, Drug: BI 409306, Drug: Placebo
Treatment sequence: T2-T3-R	Experimental	Drug: BI 409306, Drug: Placebo, Drug: BI 425809
Treatment sequence: T2-R-T3	Experimental	Drug: BI 409306, Drug: Placebo, Drug: BI 425809
Treatment sequence: T3-R-T1	Experimental	Drug: Lamotrigine, Drug: Placebo, Drug: BI 425809
Treatment sequence: T3-T1-R	Experimental	Drug: Lamotrigine, Drug: Placebo, Drug: BI 425809
Treatment sequence: T3-T2-R	Experimental	Drug: BI 409306, Drug: Placebo, Drug: BI 425809
Treatment sequence: T3-R-T2	Experimental	Drug: BI 409306, Drug: Placebo, Drug: BI 425809
Treatment sequence: R-T1-T2	Experimental	Drug: Lamotrigine, Drug: BI 409306, Drug: Placebo
Treatment sequence: R-T2-T1	Experimental	Drug: Lamotrigine, Drug: BI 409306, Drug: Placebo
Treatment sequence: R-T1-T3	Experimental	Drug: Lamotrigine, Drug: Placebo, Drug: BI 425809
Treatment sequence: R-T3-T1	Experimental	Drug: Lamotrigine, Drug: Placebo, Drug: BI 425809
Treatment sequence: R-T2-T3	Experimental	Drug: BI 409306, Drug: Placebo, Drug: BI 425809
Treatment sequence: R-T3-T2	Experimental	Drug: BI 409306, Drug: Placebo, Drug: BI 425809

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 55 years (inclusive)
BMI of 18.5 to 32 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

Key exclusion criteria (8 listed)

Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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
LamotrigineTablet	Drug	Treatment sequence: R-T1-T2, Treatment sequence: R-T1-T3, Treatment sequence: R-T2-T1, Treatment sequence: R-T3-T1, Treatment sequence: T1-R-T2, Treatment sequence: T1-R-T3, Treatment sequence: T1-T2-R, Treatment sequence: T1-T3-R, Treatment sequence: T2-R-T1, Treatment sequence: T2-T1-R, Treatment sequence: T3-R-T1, Treatment sequence: T3-T1-R
BI 409306Film-coated tablet	Drug	Treatment sequence: R-T1-T2, Treatment sequence: R-T2-T1, Treatment sequence: R-T2-T3, Treatment sequence: R-T3-T2, Treatment sequence: T1-R-T2, Treatment sequence: T1-T2-R, Treatment sequence: T2-R-T1, Treatment sequence: T2-R-T3, Treatment sequence: T2-T1-R, Treatment sequence: T2-T3-R, Treatment sequence: T3-R-T2, Treatment sequence: T3-T2-R
PlaceboTablet, Film-coated tablet	Drug	Treatment sequence: R-T1-T2, Treatment sequence: R-T1-T3, Treatment sequence: R-T2-T1, Treatment sequence: R-T2-T3, Treatment sequence: R-T3-T1, Treatment sequence: R-T3-T2, Treatment sequence: T1-R-T2, Treatment sequence: T1-R-T3, Treatment sequence: T1-T2-R, Treatment sequence: T1-T3-R, Treatment sequence: T2-R-T1, Treatment sequence: T2-R-T3, Treatment sequence: T2-T1-R, Treatment sequence: T2-T3-R, Treatment sequence: T3-R-T1, Treatment sequence: T3-R-T2, Treatment sequence: T3-T1-R, Treatment sequence: T3-T2-R
BI 425809Film-coated tablet	Drug	Treatment sequence: R-T1-T3, Treatment sequence: R-T2-T3, Treatment sequence: R-T3-T1, Treatment sequence: R-T3-T2, Treatment sequence: T1-R-T3, Treatment sequence: T1-T3-R, Treatment sequence: T2-R-T3, Treatment sequence: T2-T3-R, Treatment sequence: T3-R-T1, Treatment sequence: T3-R-T2, Treatment sequence: T3-T1-R, Treatment sequence: T3-T2-R

Primary outcome

Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine
Time frame: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
Paired Associate Learning (PAL) assesses visual memory and new learning. Boxes are displayed on the screen and open in turn to reveal a number of patterns. Participants are instructed to try to remember the location in which each pattern was shown. After all the boxes have been opened, each pattern is then shown in the center of the screen in a randomised order, and the participant touches the box in which the pattern was located. If an error is made, all the patterns are re-presented to remind the participant of their locations. The PALTEA28 evaluates the number of errors committed by the subject plus an adjustment for the estimated number of errors they would have made on any stages that were not reached. Calculated across all assessed two, four, six and eight box trials.

2 secondary outcomes

Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine
Time frame: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
Rapid Visual Information Processing A' Prime (RVPA) on Ketamine
Time frame: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.

Results and safety

Results posted to the registry on 12 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence: R-T3-T2	3	3
Treatment Sequence: R-T3-T1	2	2
Treatment Sequence: R-T2-T3	2	1
Treatment Sequence: R-T2-T1	2	2
Treatment Sequence: R-T1-T3	2	2
Treatment Sequence: R-T1-T2	2	1
Treatment Sequence: T3-R-T2	2	2
Treatment Sequence: T3-R-T1	2	2
Treatment Sequence: T3-T2-R	2	2
Treatment Sequence: T3-T1-R	2	2
Treatment Sequence: T2-R-T3	2	2
Treatment Sequence: T2-R-T1	2	2
Treatment Sequence: T2-T3-R	3	2
Treatment Sequence: T2-T1-R	2	2
Treatment Sequence: T1-R-T3	2	2
Treatment Sequence: T1-R-T2	3	2
Treatment Sequence: T1-T3-R	2	2
Treatment Sequence: T1-T2-R	3	2

Primary outcome: Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine

Time frame: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.. Least squares mean (Standard Error). Unit: Errors

Measure	Placebo (R) n = 34	25 mg BI 425809 (T3) n = 23	50 mg BI 409306 (T2) n = 23	300 mg Lamotrigine (T1) n = 26
Value	24.169 (2.5972)	23.829 (3.2275)	28.170 (3.2334)	22.911 (3.0850)

Placebo (R) vs 25 mg BI 425809 (T3): Difference of adjusted means: -0.339 (95% CI -7.975 to 7.297), p = 0.9296, ANCOVA
Placebo (R) vs 50 mg BI 409306 (T2): Difference of adjusted means: 4.002 (95% CI -3.631 to 11.634), p = 0.2990, ANCOVA
Placebo (R) vs 300 mg Lamotrigine (T1): Difference of adjusted means: -1.258 (95% CI -8.565 to 6.050), p = 0.7322, ANCOVA

Population analysed: Pharmacodynamic (PD) set (PDS): PD analyses were based on the PDS which was defined as all randomised subjects who performed the post ketamine tests in at least one period. Number of participants differs due to incomplete crossover design.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From intake of first study drug (00:00h planned time) up to Day 11 (03:00h planned time); Residual Effect Period (REP) of 11 days was used for each study treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (R)	0 of 37 (0%)	10 of 37 (27%)	0 of 37
25mg BI 425809 (T3)	0 of 24 (0%)	5 of 24 (20.8%)	0 of 24
50mg BI 409306 (T2)	0 of 25 (0%)	5 of 25 (20%)	0 of 25
300 mg Lamotrigine (T1)	0 of 26 (0%)	2 of 26 (7.7%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

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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.

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lamotrigine, BI 409306 and BI 425809 in people with Healthy, run by Boehringer Ingelheim at 2 sites 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 10 inclusion and 8 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 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 2 sites 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 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.

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 12 Mar 2024). 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?

Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine (time frame: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.). 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 NCT04602221.

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.