Trial Outcomes & Findings for ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD) (NCT NCT03113968)

Last Updated: 2023-09-28

Results Overview

Response is defined as at least a 50% improvement in the QIDS-SR-16 scale from baseline to the End of Treatment visit. The End of Treatment visit will occur 3-5 weeks after the Baseline visit.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

403 participants

Primary outcome timeframe

Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks

Results posted on

2023-09-28

Participant Flow

From March 2017 - September 2022, outpatients or inpatients referred by their clinical providers to a site's ECT service for treatment were invited to participate in the study. Patients suffering from TRD who were interested in participation were enrolled after providing written informed consent.

Of 2321 patients assessed, 436 met the inclusion criteria and were screened. 33 had screen failures and 403 were randomized.

Participant milestones

Participant milestones
Measure	Electroconvulsive Therapy (ECT) Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion. electroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.	Ketamine Infusion Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion. Ketamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.
Overall Study STARTED	203	200
Overall Study COMPLETED	172	196
Overall Study NOT COMPLETED	31	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Electroconvulsive Therapy (ECT) Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion. electroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.	Ketamine Infusion Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion. Ketamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.
Overall Study Withdrawal by Subject	31	4

Baseline Characteristics

ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electroconvulsive Therapy (ECT) n=203 Participants Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion. electroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.	Ketamine Infusion n=200 Participants Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion. Ketamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.	Total n=403 Participants Total of all reporting groups
Age, Continuous	47.1 years STANDARD_DEVIATION 14.1 • n=99 Participants	45.6 years STANDARD_DEVIATION 14.8 • n=107 Participants	46.3 years STANDARD_DEVIATION 14.4 • n=206 Participants
Sex: Female, Male Female	100 Participants n=99 Participants	106 Participants n=107 Participants	206 Participants n=206 Participants
Sex: Female, Male Male	103 Participants n=99 Participants	94 Participants n=107 Participants	197 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=99 Participants	24 Participants n=107 Participants	35 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	192 Participants n=99 Participants	176 Participants n=107 Participants	368 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	7 Participants n=99 Participants	10 Participants n=107 Participants	17 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	12 Participants n=99 Participants	10 Participants n=107 Participants	22 Participants n=206 Participants
Race (NIH/OMB) White	182 Participants n=99 Participants	173 Participants n=107 Participants	355 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	6 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
BMI	30.4 kg/m^2 STANDARD_DEVIATION 7.9 • n=99 Participants	29.5 kg/m^2 STANDARD_DEVIATION 7.4 • n=107 Participants	29.9 kg/m^2 STANDARD_DEVIATION 7.6 • n=206 Participants
Inpatient at first treatment	21 Participants n=99 Participants	23 Participants n=107 Participants	44 Participants n=206 Participants
Age of onset of First Major Depression - yrs	19.4 years STANDARD_DEVIATION 11 • n=99 Participants	19.7 years STANDARD_DEVIATION 11.5 • n=107 Participants	19.5 years STANDARD_DEVIATION 11.2 • n=206 Participants
Number of Past Major Depression Episodes	5 Episodes n=99 Participants	5 Episodes n=107 Participants	5 Episodes n=206 Participants
Duration of Current Episode - month	24 months n=99 Participants	24 months n=107 Participants	24 months n=206 Participants
Number of Patients with Family History of Depression	160 Participants n=99 Participants	154 Participants n=107 Participants	314 Participants n=206 Participants
Attempted Suicide	84 Participants n=99 Participants	73 Participants n=107 Participants	157 Participants n=206 Participants
Previous ECT	21 Participants n=99 Participants	23 Participants n=107 Participants	44 Participants n=206 Participants
Previous Ketamine	8 Participants n=99 Participants	14 Participants n=107 Participants	22 Participants n=206 Participants
16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)	18.2 units on a scale STANDARD_DEVIATION 4.2 • n=99 Participants	17.9 units on a scale STANDARD_DEVIATION 4.1 • n=107 Participants	18.1 units on a scale STANDARD_DEVIATION 4.1 • n=206 Participants
Montgomery-Åsberg Rating Scale (MADRS)	32.6 units on a scale STANDARD_DEVIATION 6 • n=99 Participants	32.3 units on a scale STANDARD_DEVIATION 6.2 • n=107 Participants	32.5 units on a scale STANDARD_DEVIATION 6.1 • n=206 Participants
Clinical Global Impression-Severity (CGI-S) scale	5.2 units on a scale STANDARD_DEVIATION 0.6 • n=99 Participants	5.0 units on a scale STANDARD_DEVIATION 0.6 • n=107 Participants	5.1 units on a scale STANDARD_DEVIATION 0.6 • n=206 Participants

PRIMARY outcome

Timeframe: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks

Population: Modified Intention-to-treat Population (i.e., participants with at least one treatment and at least one follow-up measurement)

Response is defined as at least a 50% improvement in the QIDS-SR-16 scale from baseline to the End of Treatment visit. The End of Treatment visit will occur 3-5 weeks after the Baseline visit.

Outcome measures

Outcome measures
Measure	Electroconvulsive Therapy (ECT) n=170 Participants Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion. electroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.	Ketamine Infusion n=195 Participants Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion. Ketamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.
Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16)	70 Participants	108 Participants

SECONDARY outcome

Timeframe: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks

Population: Modified intention-to-treat population (i.e., participants with at least one treatment and at least one follow-up measurement). One participant in the ECT group had missing baseline MADRS and was further excluded.

The outcome measure was the percentage of responders at the end-of-treatment visit, defined as a ≥50% decrease in MADRS score from the baseline visit (i.e., first treatment visit) to the end-of-treatment visit (within 3 days of last treatment).

Outcome measures

Outcome measures
Measure	Electroconvulsive Therapy (ECT) n=169 Participants Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion. electroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.	Ketamine Infusion n=195 Participants Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion. Ketamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.
Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS)	70 Participants	99 Participants

Adverse Events

Electroconvulsive Therapy (ECT)

Serious events: 4 serious events

Other events: 27 other events

Deaths: 0 deaths

Ketamine Infusion

Serious events: 5 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Electroconvulsive Therapy (ECT) n=170 participants at risk Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion. electroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.	Ketamine Infusion n=195 participants at risk Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion. Ketamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.
Cardiac disorders Chest pain	0.00% 0/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	0.51% 1/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Infections and infestations Infection requiring antibiotics	0.59% 1/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	0.00% 0/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Psychiatric disorders Homicidal ideation	0.59% 1/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	0.00% 0/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Psychiatric disorders Aborted suicide attempt (gesture)	0.00% 0/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	0.51% 1/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Psychiatric disorders Suicidal ideation	0.59% 1/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	1.5% 3/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Cardiac disorders Asystole	0.59% 1/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	0.00% 0/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.

Other adverse events

Other adverse events
Measure	Electroconvulsive Therapy (ECT) n=170 participants at risk Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion. electroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.	Ketamine Infusion n=195 participants at risk Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion. Ketamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.
General disorders Headache	7.1% 12/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	8.2% 16/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Cardiac disorders Hypertension (severe / prolonged)	2.4% 4/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	3.1% 6/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Musculoskeletal and connective tissue disorders Muscle Pain / Weakness	5.3% 9/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	0.51% 1/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Gastrointestinal disorders Nausea	3.5% 6/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	5.1% 10/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Musculoskeletal and connective tissue disorders Non-Cardiac Jaw Pain	2.4% 4/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	0.00% 0/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Psychiatric disorders Panic	1.8% 3/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	2.1% 4/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.
Psychiatric disorders Suicidal Ideation	1.2% 2/170 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.	2.1% 4/195 • Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline) Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.

Additional Information

Dr. Amit Anand

Department of Psychiatry, Mass General Brigham, and Harvard Medical School

Phone: 6177266421

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place