DepressionPhase 1/2NCT03237286
Intravenous Ketamine Plus Neurocognitive Training for Depression
A Phase 1/2 study testing Intravenous ketamine and Computer-based Cognitive Training in people with Depression, run by Rebecca Price at 1 site in United States.
Trial summary
This study has two aims: 1) to characterize the effects of intravenous ketamine on neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic intervention for depression combining intravenous ketamine with neurocognitive training. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Intravenous ketamine and Computer-based Cognitive Training
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 18 Oct 2022
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will:
- be between the ages of 18 and 60 years,
- have not responded to one or more adequate trials of FDA-approved antidepressants within the current depressive episode, determined by Antidepressant Treatment History Form
- score ≥ 25 on the Montgomery Asberg Depression Rating Scale (MADRS)
- score >1SD above the normative mean on the Cognitive Triad Inventory "self" subscale *OR* <1SD below the normative mean on the Rosenberg self-esteem scale
- possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
- agree to sign a release of information (ROI), identifying another individual [friend, family member, etc.] as a contact person while the patient is enrolled in the study.
Who cannot join
- Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., substance use disorder); or lifetime recreational ketamine or PCP use
- Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
- Failure to meet standard MRI inclusion criteria: those who have cardiac pacemakers, neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results.
- Current pregnancy or breastfeeding, or failure to engage in an effective birth control strategy throughout the duration of the study
- Acute suicidality or other psychiatric crises requiring treatment escalation.
- Changes made to treatment regimen within 4 weeks of baseline assessment
Show all 18Show fewer
- Reading level <6th grade
- For study entry, patients must be reasonable medical candidates for ketamine infusion, as determined by a board-certified physician co-investigator during study screening. Serious, unstable medical illnesses including respiratory [obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics], cardiovascular [including ischemic heart disease and uncontrolled hypertension], and neurologic [including history of severe head injury] will be exclusions.
- Clinically significant abnormal findings of laboratory parameters [including urine toxicology screen for drugs of abuse], physical examination, or ECG.
- Uncontrolled or poorly controlled hypertension, as determined by a board-certified physician co-investigator's review of vitals collected during screening and any other relevant medical history/records.
- Patients with one or more seizures without a clear and resolved etiology.
- Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening. Birth control is not an exclusion.
- Past intolerance or hypersensitivity to ketamine or midazolam.
- Patients taking medications with known activity at the NMDA or AMPA glutamate receptor [e.g., riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, D-cycloserine], or the muopioid receptor.
- Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide
- Patients who have received ECT in the past 6 months prior to Screening.
- Patients currently receiving treatment with vagus nerve stimulation (VNS) or repetitive transcranial stimulation (rTMS).
- Patients taking benzodiazepines (within 8 hours of infusion) or GABA agonists
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Testing a Synergistic, Neuroplasticity-Based Intervention for Depressive Neurocognition
This study has two aims: 1) to characterize the effects of intravenous ketamine on neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic intervention for depression combining intravenous ketamine with neurocognitive training. Three of the primary outcomes listed (fMRI functional connectivity; Implicit Association Test; cognitive flexibility testing) pertain to Aim 1. For Aim 2, one primary clinical outcome (MADRS, a clinician-administered measure of depression severity) pertains to the acute (30-day) phase, while the QIDS (a self-report measure of depression severity) becomes the primary clinical outcome during the 12-month naturalistic follow-up.
Read the detailed description
This study measures clinical and mechanistic outcome trajectories following ketamine (with or without adjunctive neurocognitive training) measured over an acute (30-day) period; and subsequently (for a subset of measures) over a 12-month naturalistic follow-up period.
NOTE: Corrections have been made to the "Time Frame" entries for all primary/secondary outcomes after identifying errors stemming from the study team's misunderstanding of the "Time Frame" query. Initially, the "Time Frame" query was misinterpreted to mean the range (minimum to maximum) length of the time interval over which any given assessment visit might query symptoms, and were therefore assigned erroneous values ("1 day to 2 weeks"; "1 day to lifetime") reflecting the time interval(s) queried by the instrument (e.g. at the +24 hours timepoint, symptoms are queried over a 1-day interval; at other assessment points, they could be queried over a 2-week interval for some measures, or over the entire lifetime for other measures). After recognizing this misinterpretation, the values have been adjusted to accurately reflect the a priori analytic plan.
- Conditions
- Depression
- Being tested
- Intravenous ketamine, Computer-based Cognitive Training
- Keywords
- depression, ketamine, neurocognitive, fMRI, cognitive training
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ketamineDrug
Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression.
Computer-based Cognitive TrainingBehavioural
Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine "window of opportunity" might extend relief from depression.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine + Cognitive Training | Experimental | Not described Receives: Drug: Intravenous ketamine; Behavioral: Computer-based Cognitive Training |
| Ketamine + Sham Training | Sham comparator | Not described Receives: Drug: Intravenous ketamine |
| Saline + Cognitive Training | Placebo comparator | Not described Receives: Behavioral: Computer-based Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Measured: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Executive-salience Network Functional Connectivity
fMRI measure (beta weights where larger beta weight = stronger connectivity)
Measured: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
Implicit Self-representations
Implicit Association Test composite difference score (performance-based measure; range = -inf-inf; high score=worse outcome; negatively signed value indicates associating oneself more strongly with positive than negative attributes)
Measured: Trajectories from 24 hours through Day 30 post-infusion, Day 5 reported
Cognitive Flexibility
Neurocognitive testing via NIH Toolbox DCCS fully-corrected T-scores (range = 0-100; high score=better outcome)
Measured: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: Trajectories from Day 30 through 12 months post-infusion (naturalistic follow-up), Month 12 reported
Secondary outcomes (15)
Executive-salience Network Functional Connectivity During Resting State
fMRI measure (beta weights where larger beta weight = stronger connectivity)
Measured: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
Affective Flexibility
'D-Prime' discrimination Z-score measured via accuracy of responses during the Affective Go/No-Go task (range: -inf-inf; high score=better performance; Z-score of 0=the sample mean)
Measured: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
PROMIS Measures-depression
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-anger
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-positive Affect
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-cognitive Function
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-substance Use
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported substance use Raw score range: 0-35 (higher score = worse outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-alcohol
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported alcohol use T-score range: 0-100 (higher score = worse outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Cognitive Triad Inventory
Negative perceptions of self, future, \& world (range=36-252; higher score = better outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Columbia-Suicide Severity Rating Scale
Suicidality and patient safety (most severe ideation score, range=0-5; higher score = worse outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
WHO Disability Assessment Scale (SR)
Global functioning (range=0-48; higher score = worse outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Cognitive Flexibility Scale
Self-reported cognitive flexibility (range=12-72; higher score = better outcome)
Measured: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Neuroplasticity-related Markers in Blood
ketamine metabolite (2R,6R)-HNK concentration levels (range=0-inf; higher score = greater concentration in blood)
Measured: 40min post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Dec 2017
- Primary completion18 Oct 2022
- Study completion18 Oct 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Price
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Rebecca Price, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237286
- Sponsor's protocol ID
- STUDY19040414
- Other IDs
- 1R01MH113857
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2017
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will comply with all NIMH guidelines regarding data repository/sharing.
Publications
Hossein S, Woody ML, Panny B, Spotts C, Wallace ML, Mathew SJ, Howland RH, Price RB. Functional connectivity subtypes during a positive mood induction: Predicting clinical response in a randomized controlled trial of ketamine for treatment-resistant depression. J Psychopathol Clin Sci. 2025 Apr;134(3):228-238. doi: 10.1037/abn0000951. Epub 2024 Sep 23.
PubMed 39311825Price RB, Wallace ML, Mathew SJ, Howland RH. One-Year Outcomes Following Intravenous Ketamine Plus Digital Training Among Patients with Treatment-Resistant Depression: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2312434. doi: 10.1001/jamanetworkopen.2023.12434.
PubMed 37155171Price RB, Panny B, Degutis M, Griffo A. Repeated measurement of implicit self-associations in clinical depression: Psychometric, neural, and computational properties. J Abnorm Psychol. 2021 Feb;130(2):152-165. doi: 10.1037/abn0000651. Epub 2020 Dec 3.
PubMed 33271040
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Synergistic, Neuroplasticity-Based Intervention for Depressive Neurocognition
- ClinicalTrials.gov ID
- NCT03237286
- Acronym / sponsor ID
- STUDY19040414
- Conditions
- Depression
- Keywords
- depression, ketamine, neurocognitive, fMRI, cognitive training
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Rebecca PriceUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has two aims: 1) to characterize the effects of intravenous ketamine on neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic intervention for depression combining intravenous ketamine with neurocognitive training. Three of the primary outcomes listed (fMRI functional connectivity; Implicit Association Test; cognitive flexibility testing) pertain to Aim 1. For Aim 2, one primary clinical outcome (MADRS, a clinician-administered measure of depression severity) pertains to the acute (30-day) phase, while the QIDS (a self-report measure of depression severity) becomes the primary clinical outcome during the 12-month naturalistic follow-up.
Detailed description
This study measures clinical and mechanistic outcome trajectories following ketamine (with or without adjunctive neurocognitive training) measured over an acute (30-day) period; and subsequently (for a subset of measures) over a 12-month naturalistic follow-up period.
NOTE: Corrections have been made to the "Time Frame" entries for all primary/secondary outcomes after identifying errors stemming from the study team's misunderstanding of the "Time Frame" query. Initially, the "Time Frame" query was misinterpreted to mean the range (minimum to maximum) length of the time interval over which any given assessment visit might query symptoms, and were therefore assigned erroneous values ("1 day to 2 weeks"; "1 day to lifetime") reflecting the time interval(s) queried by the instrument (e.g. at the +24 hours timepoint, symptoms are queried over a 1-day interval; at other assessment points, they could be queried over a 2-week interval for some measures, or over the entire lifetime for other measures). After recognizing this misinterpretation, the values have been adjusted to accurately reflect the a priori analytic plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine + Cognitive Training | Experimental | Drug: Intravenous ketamine, Behavioral: Computer-based Cognitive Training |
| Ketamine + Sham Training | Sham comparator | Drug: Intravenous ketamine |
| Saline + Cognitive Training | Placebo comparator | Behavioral: Computer-based Cognitive Training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- be between the ages of 18 and 60 years,
- have not responded to one or more adequate trials of FDA-approved antidepressants within the current depressive episode, determined by Antidepressant Treatment History Form
- score ≥ 25 on the Montgomery Asberg Depression Rating Scale (MADRS)
- score >1SD above the normative mean on the Cognitive Triad Inventory "self" subscale *OR* <1SD below the normative mean on the Rosenberg self-esteem scale
- possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
Key exclusion criteria (18 listed)
- Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., substance use disorder); or lifetime recreational ketamine or PCP use
- Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
- Failure to meet standard MRI inclusion criteria: those who have cardiac pacemakers, neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results.
- Current pregnancy or breastfeeding, or failure to engage in an effective birth control strategy throughout the duration of the study
- Acute suicidality or other psychiatric crises requiring treatment escalation.
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 |
|---|---|---|
| Intravenous ketamineIntravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression. | Drug | Ketamine + Cognitive Training, Ketamine + Sham Training |
| Computer-based Cognitive TrainingComputer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine "window of opportunity" might extend relief from depression. | Behavioural | Ketamine + Cognitive Training, Saline + Cognitive Training |
Primary outcome
Montgomery Asberg Depression Scale
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Executive-salience Network Functional Connectivity
Time frame: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
fMRI measure (beta weights where larger beta weight = stronger connectivity)
Implicit Self-representations
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 5 reported
Implicit Association Test composite difference score (performance-based measure; range = -inf-inf; high score=worse outcome; negatively signed value indicates associating oneself more strongly with positive than negative attributes)
Cognitive Flexibility
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Neurocognitive testing via NIH Toolbox DCCS fully-corrected T-scores (range = 0-100; high score=better outcome)
Quick Inventory of Depressive Symptoms
Time frame: Trajectories from Day 30 through 12 months post-infusion (naturalistic follow-up), Month 12 reported
Self-reported depression (range: 0-27; higher scores = worse outcome)
15 secondary outcomes
Executive-salience Network Functional Connectivity During Resting State
Time frame: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
Affective Flexibility
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
PROMIS Measures-depression
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-anxiety
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-anger
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-positive Affect
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-sleep Disturbance
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-cognitive Function
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-substance Use
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-alcohol
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Cognitive Triad Inventory
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Columbia-Suicide Severity Rating Scale
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
WHO Disability Assessment Scale (SR)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Cognitive Flexibility Scale
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Neuroplasticity-related Markers in Blood
Time frame: 40min post-infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39311825Hossein S, Woody ML, Panny B, Spotts C, Wallace ML, Mathew SJ, Howland RH, Price RB. Functional connectivity subtypes during a positive mood induction: Predicting clinical response in a randomized controlled trial of ketamine for treatment-resistant depression. J Psychopathol Clin Sci. 2025 Apr;134(3):228-238. doi: 10.1037/abn0000951. Epub 2024 Sep 23.
- Derived from this study: PubMed 37155171Price RB, Wallace ML, Mathew SJ, Howland RH. One-Year Outcomes Following Intravenous Ketamine Plus Digital Training Among Patients with Treatment-Resistant Depression: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2312434. doi: 10.1001/jamanetworkopen.2023.12434.
- Derived from this study: PubMed 33271040Price RB, Panny B, Degutis M, Griffo A. Repeated measurement of implicit self-associations in clinical depression: Psychometric, neural, and computational properties. J Abnorm Psychol. 2021 Feb;130(2):152-165. doi: 10.1037/abn0000651. Epub 2020 Dec 3.
- Individual participant dataSharing planned: Yes. We will comply with all NIMH guidelines regarding data repository/sharing.
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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.
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 Intravenous ketamine and Computer-based Cognitive Training in people with Depression, run by Rebecca Price 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 7 inclusion and 18 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 19 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2023). 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?
Montgomery Asberg Depression Scale (time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported). The study lists 5 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 NCT03237286, which also lists 3 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 19 Mar 2024.