Major Depressive DisorderNCT04239963
Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression
An observational study of Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
The overarching goal of the present study is to evaluate the effect of a subanesthetic dose of ketamine 24-hour post-injection on resting state functional connectivity, cognitive control, and reward learning. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 28 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We plan to recruit 30 TRD individuals with current MDD without psychotic features and 30 demographically matched healthy controls. All participants will be ketamine-naïve.
Who may be able to join
- All genders, races, and ethnic origins, aged between 18 and 70;
- DSM-5 diagnostic criteria for MDD (diagnosed with the use of the Structured Clinical Interview for DSM-5 (SCID-5));
- A score of ≥32 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30).
- Capable of providing written informed consent, and fluent in English;
- Right-handed;
- Treatment Resistant (as assessed using the MGH Antidepressant Response Questionnaire)
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- Have already decided to receive ketamine treatment as part of their standard clinical care
- All genders, races, and ethnic origins, aged between 18 and 70;
- Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP);
- A baseline Quick Inventory of Depressive Symptomatology (QIDS) score ≤ 5;
- A baseline Hamilton Depression Rating Scale (HDRS) score ≤ 7;
- Capable of providing written informed consent, and fluent in English;
- Right-handed;
- No first-degree relative with mood or psychotic disorder.
Who cannot join
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
- History of seizure disorder;
- History or current diagnosis of any of the following DSM-5 psychiatric illnesses: schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, substance abuse disorder;
- Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication;
- Substance use assessed by physician as dangerous for ketamine treatment;
- Untreated glaucoma;
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- Complex post-traumatic stress disorder (PTSD) with dissociation;
- Patients with a lifetime history of electroconvulsive therapy (ECT).
- Participants with a lifetime history of ketamine use.
Trial locations and contacts
1 site in 1 country.
About this study
The overarching goal of the present study is to evaluate the effect of a subanesthetic dose of ketamine 24-hour post-injection on resting state functional connectivity, cognitive control, and reward learning.
Read the detailed description
Major Depressive Disorder (MDD) participants with treatment-resistant depression (TRD) will be recruited from McLean's Ketamine clinic. Suitability for Ketamine treatment will be determined as typically done by the service - through evaluation by the clinicians on the staff of the Ketamine Service who perform psychiatric consultations and assessments for Ketamine suitability. Potential subjects will be informed about the study only after they have received a positive consultation at the clinic and have already agreed to receive the treatment.
This study consists of a set of questionnaires, urine drug screen, and electroencephalogram (EEG) recordings.
- Conditions
- Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Subjects who have no history of clinical depression or other psychological disorder | |
| Current MDD | Subjects experiencing a current episode of Major Depressive Disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials
Relative FRP response is the primary outcome measure for the probabilistic reward task (PRT).
Measured: Baseline
Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials.
Relative ERN response is the primary outcome measure for the flanker task.
Measured: Baseline
Behavioral Performance on the Probabilistic Reward Task (PRT)
The Probablilistic Reward Task operationalizes positive reinforcement learning
Measured: Baseline
Behavioral Performance on the Flanker Task
The Flanker Task is a cognitive task that measures response inhibition to assess the ability to suppress responses that are inappropriate in a particular context.
Measured: Baseline
Rumination
Severity of rumination will be assessed using the Rumination Response Scale (RRS). The RRS has a minimum score of 22 and a maximum score of 88. Higher scores indicate higher degrees of ruminative symptoms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start17 Aug 2020
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Pizzagalli, Mclean Hospital
- Investigators
- Diego Pizzagalli, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239963
- Sponsor's protocol ID
- 2019P003371
- Status last verified
- Oct 2024
- First submitted
- 15 Jan 2020
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT04239963
- Acronym / sponsor ID
- 2019P003371
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 27 Jan 2020 (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.
The overarching goal of the present study is to evaluate the effect of a subanesthetic dose of ketamine 24-hour post-injection on resting state functional connectivity, cognitive control, and reward learning.
Detailed description
Major Depressive Disorder (MDD) participants with treatment-resistant depression (TRD) will be recruited from McLean's Ketamine clinic. Suitability for Ketamine treatment will be determined as typically done by the service - through evaluation by the clinicians on the staff of the Ketamine Service who perform psychiatric consultations and assessments for Ketamine suitability. Potential subjects will be informed about the study only after they have received a positive consultation at the clinic and have already agreed to receive the treatment.
This study consists of a set of questionnaires, urine drug screen, and electroencephalogram (EEG) recordings.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Subjects who have no history of clinical depression or other psychological disorder |
| Current MDD | – | –Subjects experiencing a current episode of Major Depressive Disorder. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to recruit 30 TRD individuals with current MDD without psychotic features and 30 demographically matched healthy controls. All participants will be ketamine-naïve.
Key inclusion criteria (14 listed)
- All genders, races, and ethnic origins, aged between 18 and 70;
- DSM-5 diagnostic criteria for MDD (diagnosed with the use of the Structured Clinical Interview for DSM-5 (SCID-5));
- A score of ≥32 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30).
- Capable of providing written informed consent, and fluent in English;
- Right-handed;
Key exclusion criteria (9 listed)
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
- History of seizure disorder;
- History or current diagnosis of any of the following DSM-5 psychiatric illnesses: schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, substance abuse disorder;
- Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication;
- Substance use assessed by physician as dangerous for ketamine treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials
Time frame: Baseline
Relative FRP response is the primary outcome measure for the probabilistic reward task (PRT).
Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials.
Time frame: Baseline
Relative ERN response is the primary outcome measure for the flanker task.
Behavioral Performance on the Probabilistic Reward Task (PRT)
Time frame: Baseline
The Probablilistic Reward Task operationalizes positive reinforcement learning
Behavioral Performance on the Flanker Task
Time frame: Baseline
The Flanker Task is a cognitive task that measures response inhibition to assess the ability to suppress responses that are inappropriate in a particular context.
Rumination
Time frame: Baseline
Severity of rumination will be assessed using the Rumination Response Scale (RRS). The RRS has a minimum score of 22 and a maximum score of 88. Higher scores indicate higher degrees of ruminative symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
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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.
Diego Pizzagalli, PhD principal investigator
Mclean Hospital
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, run by Mclean Hospital 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 14 inclusion and 9 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 30 Oct 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials (time frame: Baseline). 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?
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 30 Oct 2024.