Depression, UnipolarPhase 1/2NCT04916548
Repeated Neurocognitive Measurements in Depressed Patients
A Phase 1/2 study testing Intravenous Ketamine in people with Depression, Unipolar, run by Rebecca Price at 1 site in United States.
Trial summary
In this project, we will A) track the functioning of a collection of potential neurobiological targets for depression over time, B) examine how fluctuations in the functioning of those targets relates to real-world functioning, and C) in a subset of the sample, determine how the functioning in those targets is altered… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Unipolar
- What is being tested?
- Intravenous Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 15 Aug 2023
- 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
- All participants will:
- be between the ages of 18 and 60 years,
- score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D)
- possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
Who cannot join
- All participants:
- Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
- 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. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results.
- Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.
- Changes made to treatment regimen within 4 weeks of baseline assessment.
- Reading level <6th grade as per patient self-report.
Show all 19Show fewer
- Patients who have received ECT in the past 2 months prior to Screening.
- Ketamine phase subsample additional exclusion criteria:
- Patients currently taking any psychotropic medication.
- Lifetime recreational ketamine or PCP use
- Current pregnancy or breastfeeding
- For ketamine phase entry, patients must be reasonable medical candidates for ketamine infusion, as determined by a physician co-investigator. 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 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.
- Past intolerance or hypersensitivity to ketamine.
- Patients taking medications with known activity at the NMDA or AMPA glutamate receptor [e.g., riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, Dcycloserine], or the mu-opioid receptor.
- Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
In this project, we will A) track the functioning of a collection of potential neurobiological targets for depression over time, B) examine how fluctuations in the functioning of those targets relates to real-world functioning, and C) in a subset of the sample, determine how the functioning in those targets is altered by a single dose of ketamine.
- Conditions
- Depression, Unipolar
- Being tested
- Intravenous Ketamine
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous KetamineDrug
Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Ketamine | Experimental | Open-label ketamine infusion Receives: Drug: Intravenous Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI Intrinsic Connectivity: Default Mode Network
functional connectivity normalized correlation values within default mode network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
Measured: 24hrs post-intervention
fMRI Intrinsic Connectivity: Frontoparietal Control Network
functional connectivity normalized correlation values within frontoparietal control network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
Measured: 24hrs post-intervention
fMRI Intrinsic Connectivity: Limbic Network
functional connectivity normalized correlation values within limbic network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
Measured: 24hrs post-intervention
fMRI Intrinsic Connectivity: Salience Network
functional connectivity normalized correlation values within salience ventral attentional network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
Measured: 24hrs post-intervention
Secondary outcomes (12)
fMRI Intrinsic Connectivity: Dorsal Attention Network
functional connectivity normalized correlation values within dorsal attention network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
Measured: 24hrs post-intervention
fMRI Intrinsic Connectivity: Somatosensory Motor Network
functional connectivity normalized correlation values within somatosensory motor network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
Measured: 24hrs post-intervention
fMRI Intrinsic Connectivity: Visual Network
functional connectivity normalized correlation values within visual network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
Measured: 24hrs post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Measured: 24hrs post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Measured: 5 days post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Measured: 12 days post-intervention
Hamilton Depression Rating Scale (Modified Score)
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Measured: 24hrs post-intervention
Hamilton Depression Rating Scale (Modified Score)
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Measured: 5 days post-intervention
Hamilton Depression Rating Scale (Modified Score)
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Measured: 12 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: 24hrs post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: 5 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: 12 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start16 Sep 2021
- Primary completion15 Jul 2023
- Study completion15 Aug 2023
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 Depression, UnipolarStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Price
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rebecca Price, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916548
- Sponsor's protocol ID
- STUDY21040075
- Status last verified
- Jul 2024
- First submitted
- 28 May 2021
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Neurocognitive Measurements in Depressed Patients
- ClinicalTrials.gov ID
- NCT04916548
- Acronym / sponsor ID
- STUDY21040075
- Conditions
- Depression, Unipolar
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rebecca PriceUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Posted 20 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this project, we will A) track the functioning of a collection of potential neurobiological targets for depression over time, B) examine how fluctuations in the functioning of those targets relates to real-world functioning, and C) in a subset of the sample, determine how the functioning in those targets is altered by a single dose of ketamine.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous Ketamine | Experimental | Drug: Intravenous KetamineOpen-label ketamine infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- be between the ages of 18 and 60 years,
- score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D)
- 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 (19 listed)
- Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
- 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. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results.
- Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.
- Changes made to treatment regimen within 4 weeks of baseline assessment.
- Reading level <6th grade as per patient self-report.
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 KetamineSingle infusion of intravenous racemic ketamine (0.5mg/kg over 40min) | Drug | Intravenous Ketamine |
Primary outcome
fMRI Intrinsic Connectivity: Default Mode Network
Time frame: 24hrs post-intervention
functional connectivity normalized correlation values within default mode network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
fMRI Intrinsic Connectivity: Frontoparietal Control Network
Time frame: 24hrs post-intervention
functional connectivity normalized correlation values within frontoparietal control network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
fMRI Intrinsic Connectivity: Limbic Network
Time frame: 24hrs post-intervention
functional connectivity normalized correlation values within limbic network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
fMRI Intrinsic Connectivity: Salience Network
Time frame: 24hrs post-intervention
functional connectivity normalized correlation values within salience ventral attentional network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
12 secondary outcomes
fMRI Intrinsic Connectivity: Dorsal Attention Network
Time frame: 24hrs post-intervention
fMRI Intrinsic Connectivity: Somatosensory Motor Network
Time frame: 24hrs post-intervention
fMRI Intrinsic Connectivity: Visual Network
Time frame: 24hrs post-intervention
Montgomery-Asberg Depression Rating Scale
Time frame: 24hrs post-intervention
Montgomery-Asberg Depression Rating Scale
Time frame: 5 days post-intervention
Montgomery-Asberg Depression Rating Scale
Time frame: 12 days post-intervention
Hamilton Depression Rating Scale (Modified Score)
Time frame: 24hrs post-intervention
Hamilton Depression Rating Scale (Modified Score)
Time frame: 5 days post-intervention
Hamilton Depression Rating Scale (Modified Score)
Time frame: 12 days post-intervention
Quick Inventory of Depressive Symptoms
Time frame: 24hrs post-intervention
Quick Inventory of Depressive Symptoms
Time frame: 5 days post-intervention
Quick Inventory of Depressive Symptoms
Time frame: 12 days post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Depression, Unipolar
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
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 in people with Depression, Unipolar, 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 4 inclusion and 19 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 20 Aug 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?
Yes. Results are posted in the registry (first posted 20 Aug 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?
fMRI Intrinsic Connectivity: Default Mode Network (time frame: 24hrs post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.