Trial Outcomes & Findings for Antidepressant Effects of TS-161 in Treatment-Resistant Depression (NCT NCT04821271)

NCT ID: NCT04821271

Last Updated: 2025-06-10

Results Overview

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline and day 21 (week 3). The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Analysis was the change in total score between baseline and day 21. Change was calculated as the estimated marginal MADRS total score means using a linear mixed model regression.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: Baseline and day 21 (week 3)
• Results posted on: 2025-06-10

Participant Flow

Participant milestones

Measure	TS-161, Then Placebo Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance), followed by Placebo capsule orally once per day for three weeks.	Placebo, Then TS-161 Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks, followed by TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).
Period 1 STARTED	6	5
Period 1 TS-161 100mg Then 50mg	1	0
Period 1 COMPLETED	4	5
Period 1 NOT COMPLETED	2	0
Period 2 STARTED	4	5
Period 2 TS-161 100mg, Then 50mg, Then 100mg	0	1
Period 2 COMPLETED	4	5
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	TS-161, Then Placebo Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance), followed by Placebo capsule orally once per day for three weeks.	Placebo, Then TS-161 Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks, followed by TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).
Period 1 Withdrawal by Subject	2	0

Baseline Characteristics

Antidepressant Effects of TS-161 in Treatment-Resistant Depression

Baseline characteristics by cohort

Measure	Overall Study Participants n=11 Participants Participants with major depressive disorder (MDD) were randomized to receive either TS-161 100mg (with option to dose to 50 mg due to drug intolerance) or Placebo capsule orally once per day for three weeks followed by subsequent intervention for three weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and day 21 (week 3)

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline and day 21 (week 3). The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Analysis was the change in total score between baseline and day 21. Change was calculated as the estimated marginal MADRS total score means using a linear mixed model regression.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score	28.02 Units on a scale Standard Error 1.9	27.79 Units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: 230 minutes following the first treatment dose

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Montgomery-Asberg Depression Rating Scale (MADRS) mean total score at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration. The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal means at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration were calculated using a linear mixed model regression.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Total Score	26.39 Units on a scale Standard Error 1.82	25.01 Units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: Day 1 following the first treatment dose

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Montgomery-Asberg Depression Rating Scale (MADRS) mean total score at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration. The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal means at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration were calculated using a linear mixed model regression.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Total Score	28.49 Units on a scale Standard Error 1.82	25.68 Units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: Day 2 following the first treatment dose

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Montgomery-Asberg Depression Rating Scale (MADRS) mean total score at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration. The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal means at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration were calculated using a linear mixed model regression.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Total Score	28.8 Units on a scale Standard Error 1.90	25.79 Units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: Day 3 following the first treatment dose

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Montgomery-Asberg Depression Rating Scale (MADRS) mean total score at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration. The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal means at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration were calculated using a linear mixed model regression.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Total Score	27.91 Units on a scale Standard Error 1.90	27.12 Units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: Day 7 following the first treatment dose

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Montgomery-Asberg Depression Rating Scale (MADRS) mean total score at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration. The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal means at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration were calculated using a linear mixed model regression.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Total Score	26.59 Units on a scale Standard Error 1.82	27.24 Units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: Day 14 following the first treatment dose

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Montgomery-Asberg Depression Rating Scale (MADRS) mean total score at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration. The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal means at 230 minutes and 1, 2, 3, 7, and 14 days following the first treatment administration were calculated using a linear mixed model regression.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Total Score	29.13 Units on a scale Standard Error 1.90	27.01 Units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: Up to three weeks after each intervention

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Number of participants who met remission criteria at any time point after intervention. Remission was defined as Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤10 after intervention. The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Number of Participants Who Met Remission Criteria at Any Time Point	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to three weeks after each intervention

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Number of participants who met response criteria at any timepoint after intervention. Response was defined as a ≥50% reduction from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Number of Participants Who Met Response Criteria	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

The Hamilton Depression Rating Scale (HDRS) mean total score at 230 minutes and 1, 2, 3, 7, 14, and 21 days following the first treatment administration. HDRS is a widely used observational rating measure of depression severity. The HDRS contains 21 items, but four questions are not added to the numerical total score. The first 17 items are scored on a 3 (0-2) or 5 (0-4) point scale, with total score range between 0 and 52. Scores of 0-7 are considered normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. For each crossover period, the HDRS was completed 1440 minutes (24 hours) before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal HDRS total score means were calculated using a linear mixed model regression that controlled for baseline HDRS and allowed treatment differences to vary by time point.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Hamilton Depression Rating Scale (HDRS) Mean Total Scores 230 minutes	20.48 Units on a scale Standard Error 1.71	18.21 Units on a scale Standard Error 1.63
Hamilton Depression Rating Scale (HDRS) Mean Total Scores Day 3	21.99 Units on a scale Standard Error 1.76	19.88 Units on a scale Standard Error 1.63
Hamilton Depression Rating Scale (HDRS) Mean Total Scores Day 7	19.58 Units on a scale Standard Error 1.71	19.88 Units on a scale Standard Error 1.63
Hamilton Depression Rating Scale (HDRS) Mean Total Scores Day 14	22.55 Units on a scale Standard Error 1.76	20.43 Units on a scale Standard Error 1.63
Hamilton Depression Rating Scale (HDRS) Mean Total Scores Day 21	21.77 Units on a scale Standard Error 1.76	20.76 Units on a scale Standard Error 1.63
Hamilton Depression Rating Scale (HDRS) Mean Total Scores Day 1	19.78 Units on a scale Standard Error 1.71	18.32 Units on a scale Standard Error 1.63
Hamilton Depression Rating Scale (HDRS) Mean Total Scores Day 2	20.99 Units on a scale Standard Error 1.76	18.65 Units on a scale Standard Error 1.63

SECONDARY outcome

Timeframe: 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

The Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) mean total score at 230 minutes and 1, 2, 3, 7, 14, and 21 days following the first treatment administration. HAM-A is a widely used observational rating measure of anxiety severity. This scale was administered to assess the severity of anxiety and its improvement during the course of therapy. The scale consists of 14 items. Each item is rated on a scale of 0 to 4, with total score range between 0 and 56. A higher score represents greater symptom severity. Total score <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe severity. For each crossover period, the HAM-A was completed 1440 minutes (24 hours) before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal HAM-A total score means were calculated using a linear mixed model regression that controlled for baseline HAM-A and allowed treatment differences to vary by time point.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Mean Total Scores 230 minutes	10.12 Units on a scale Standard Error 1.16	8.73 Units on a scale Standard Error 1.09
Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Mean Total Scores Day 1	10.32 Units on a scale Standard Error 1.16	10.28 Units on a scale Standard Error 1.09
Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Mean Total Scores Day 2	11.85 Units on a scale Standard Error 1.21	9.84 Units on a scale Standard Error 1.09
Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Mean Total Scores Day 7	10.02 Units on a scale Standard Error 1.16	12.62 Units on a scale Standard Error 1.09
Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Mean Total Scores Day 14	11.29 Units on a scale Standard Error 1.21	11.17 Units on a scale Standard Error 1.09
Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Mean Total Scores Day 21	10.74 Units on a scale Standard Error 1.21	12.73 Units on a scale Standard Error 1.09
Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Mean Total Scores Day 3	13.18 Units on a scale Standard Error 1.21	12.62 Units on a scale Standard Error 1.09

SECONDARY outcome

Timeframe: 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

The Snaith-Hamilton Pleasure Scale (SHAPS) mean total score at 230 minutes and 1, 2, 3, 7, 14, and 21 days following the first treatment administration. The SHAPS is a 14-item self-report measure of hedonic or pleasurable experiences or the lack of hedonic experiences (e.g., interests, social interactions, or sensory experiences) in adults and for assessment of any changes. Each item is rated on a scale of 1 to 4 (1 = definitely agree or strongly agree, 4 = strongly disagree) with total score range between 14 and 56. Lower scores indicate greater levels of anhedonia. For each crossover period, the SHAPS was completed 1440 minutes (24 hours) before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal SHAPS total score means were calculated using a linear mixed model regression that controlled for baseline SHAPS and allowed treatment differences to vary by time point.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Snaith-Hamilton Pleasure Scale (SHAPS) Mean Total Scores Day 1	36.26 Units on a scale Standard Error 1.3	35.47 Units on a scale Standard Error 1
Snaith-Hamilton Pleasure Scale (SHAPS) Mean Total Scores 230 minutes	36.86 Units on a scale Standard Error 1.3	36.92 Units on a scale Standard Error 1
Snaith-Hamilton Pleasure Scale (SHAPS) Mean Total Scores Day 2	37.52 Units on a scale Standard Error 1.34	37.03 Units on a scale Standard Error 1
Snaith-Hamilton Pleasure Scale (SHAPS) Mean Total Scores Day 3	39.74 Units on a scale Standard Error 1.34	37.92 Units on a scale Standard Error 1
Snaith-Hamilton Pleasure Scale (SHAPS) Mean Total Scores Day 7	38.26 Units on a scale Standard Error 1.3	37.8 Units on a scale Standard Error 1
Snaith-Hamilton Pleasure Scale (SHAPS) Mean Total Scores Day 14	39.07 Units on a scale Standard Error 1.34	38.36 Units on a scale Standard Error 1
Snaith-Hamilton Pleasure Scale (SHAPS) Mean Total Scores Day 21	39.29 Units on a scale Standard Error 1.34	37.36 Units on a scale Standard Error 1

SECONDARY outcome

Timeframe: 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

The Temporal Experience of Pleasure Scale (TEPS) mean total score at 230 minutes and 1, 2, 3, 7, 14, and 21 days following the first treatment administration. The TEPS is an 18-item self-report measure of consummatory and anticipatory experiences of pleasure or lack of pleasure (i.e., anhedonia) in adults and for the assessment of any changes. Each item is rated on a scale of 0 to 6 (0 = very true for me, 6 = very false for me) with total score range between 0 and 108. Lower scores indicate greater levels of anhedonia. For each crossover period, the TEPS was completed 1440 minutes (24 hours) before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal TEPS total score means were calculated using a linear mixed model regression that controlled for baseline TEPS and allowed treatment differences to vary by time point.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Temporal Experience of Pleasure Scale (TEPS) Mean Total Scores 230 minutes	48.23 Units on a scale Standard Error 2.02	51.51 Units on a scale Standard Error 3.16
Temporal Experience of Pleasure Scale (TEPS) Mean Total Scores Day 1	49.93 Units on a scale Standard Error 2.03	51.29 Units on a scale Standard Error 2.83
Temporal Experience of Pleasure Scale (TEPS) Mean Total Scores Day 14	46.51 Units on a scale Standard Error 2.64	48.29 Units on a scale Standard Error 3.62
Temporal Experience of Pleasure Scale (TEPS) Mean Total Scores Day 2	47.6 Units on a scale Standard Error 1.75	49.07 Units on a scale Standard Error 3.11
Temporal Experience of Pleasure Scale (TEPS) Mean Total Scores Day 3	46.68 Units on a scale Standard Error 1.31	49.4 Units on a scale Standard Error 2.65
Temporal Experience of Pleasure Scale (TEPS) Mean Total Scores Day 7	46.63 Units on a scale Standard Error 2.34	48.07 Units on a scale Standard Error 3.7
Temporal Experience of Pleasure Scale (TEPS) Mean Total Scores Day 21	46.7 Units on a scale Standard Error 2.6	48.18 Units on a scale Standard Error 3.65

SECONDARY outcome

Timeframe: 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

The Positive and Negative Affect Schedule (PANAS) mean total score at 230 minutes and 1, 2, 3, 7, 14, and 21 days following the first treatment administration. The PANAS is a questionnaire that assesses both positive and negative affect and consists of 20 items, 10 measuring positive affect (e.g., "excited") and 10 measuring negative affect (e.g., "upset"). Each item is rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely) with a total score ranging between 10 and 50 for each affect subscale. Higher scores indicate higher levels of positive or negative affect depending on the subscale. For each crossover period, the PANAS was completed 1440 minutes (24 hours) before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal total score means were calculated for the positive affect using a linear mixed model regression that controlled for baseline and allowed treatment differences to vary by time point.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Positive Affect Day 1	18.01 Units on a scale Standard Error 1.12	18.33 Units on a scale Standard Error 1.36
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Positive Affect Day 3	15.58 Units on a scale Standard Error 1.16	16.66 Units on a scale Standard Error 1.36
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Positive Affect Day 14	15.47 Units on a scale Standard Error 1.16	17.77 Units on a scale Standard Error 1.36
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Positive Affect Day 21	16.91 Units on a scale Standard Error 1.16	17 Units on a scale Standard Error 1.36
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Positive Affect 230 minutes	16.91 Units on a scale Standard Error 1.12	18.11 Units on a scale Standard Error 1.36
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Positive Affect Day 2	15.58 Units on a scale Standard Error 1.16	17.77 Units on a scale Standard Error 1.36
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Positive Affect Day 7	15.81 Units on a scale Standard Error 1.12	15.77 Units on a scale Standard Error 1.36

SECONDARY outcome

Timeframe: 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

The Positive and Negative Affect Schedule (PANAS) mean total score at 230 minutes and 1, 2, 3, 7, 14, and 21 days following the first treatment administration. The PANAS is a questionnaire that assesses both positive and negative affect and consists of 20 items, 10 measuring positive affect (e.g., "excited") and 10 measuring negative affect (e.g., "upset"). Each item is rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely) with a total score ranging between 10 and 50 for each affect subscale. Higher scores indicate higher levels of positive or negative affect depending on the subscale. For each crossover period, the PANAS was completed 1440 minutes (24 hours) before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal total score means were calculated for the negative affect using a linear mixed model regression that controlled for baseline and allowed treatment differences to vary by time point.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Negative Affect 230 minutes	19.93 Units on a scale Standard Error 1.18	19.5 Units on a scale Standard Error 1.47
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Negative Affect Day 1	21.63 Units on a scale Standard Error 1.18	19.5 Units on a scale Standard Error 1.47
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Negative Affect Day 14	20.78 Units on a scale Standard Error 1.26	20.94 Units on a scale Standard Error 1.47
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Negative Affect Day 2	19.67 Units on a scale Standard Error 1.26	19.72 Units on a scale Standard Error 1.47
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Negative Affect Day 3	19.11 Units on a scale Standard Error 1.26	20.83 Units on a scale Standard Error 1.47
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Negative Affect Day 7	20.33 Units on a scale Standard Error 1.18	22.39 Units on a scale Standard Error 1.47
Positive and Negative Affect Schedule (PANAS) Mean Total Score - Negative Affect Day 21	21.22 Units on a scale Standard Error 1.26	21.94 Units on a scale Standard Error 1.47

SECONDARY outcome

Timeframe: 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

The Clinician Administered Dissociative States Scale (CADSS) mean total score at 230 minutes and 1, 2, 3, 7, 14, and 21 days following the first treatment administration. The CADSS is a 28-item clinician-rated assessment of dissociative states in the moment and contains both subjective and objective items. Items are rated on a scale of 0 to 4 (0 = not at all, 4 = extreme) with total score range between 0 and 112. A higher score indicates more severe dissociation. For each crossover period, the CADSS was completed 1440 minutes (24 hours) before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose. Estimated marginal CADSS total score means were calculated using a linear mixed model regression that controlled for baseline and allowed treatment differences to vary by time point.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Clinician-Administered Dissociative States Scale (CADSS) Mean Total Score Day 2	1.05 Units on a scale Standard Error 0.25	0.98 Units on a scale Standard Error 0.65
Clinician-Administered Dissociative States Scale (CADSS) Mean Total Score Day 7	0.84 Units on a scale Standard Error 0.24	1.43 Units on a scale Standard Error 0.65
Clinician-Administered Dissociative States Scale (CADSS) Mean Total Score 230 minutes	1.24 Units on a scale Standard Error 0.24	1.98 Units on a scale Standard Error 0.65
Clinician-Administered Dissociative States Scale (CADSS) Mean Total Score Day 1	1.54 Units on a scale Standard Error 0.24	1.76 Units on a scale Standard Error 0.65
Clinician-Administered Dissociative States Scale (CADSS) Mean Total Score Day 3	0.94 Units on a scale Standard Error 0.25	1.2 Units on a scale Standard Error 0.65
Clinician-Administered Dissociative States Scale (CADSS) Mean Total Score Day 14	1.17 Units on a scale Standard Error 0.25	0.31 Units on a scale Standard Error 0.65
Clinician-Administered Dissociative States Scale (CADSS) Mean Total Score Day 21	1.39 Units on a scale Standard Error 0.25	1.2 Units on a scale Standard Error 0.65

SECONDARY outcome

Timeframe: 230 minutes, and 1 and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

The Brief Psychiatric Rating Scale (BPRS) mean total score at 230 minutes, 1 and 21 days following the first treatment administration. The BPRS is an 18-item clinician-rated scale that evaluates symptoms and behaviors that are characteristic of schizophrenia (e.g., hallucinations, unusual thought content). Each item is rated on scale of 1 (symptom not reported or observed) to 7 (very severe), with a total score range between 18 to 126. Higher scores indicate more severe symptoms of psychosis. For each crossover period, the BPRS was completed 1440 minutes (24 hours) before intervention (baseline) and 230 minutes, 1 and 21 days days following the first dose. Estimated marginal BPRS total score means were calculated using a linear mixed model regression that controlled for baseline and allowed treatment differences to vary by time point.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Brief Psychiatric Rating Scale (BPRS) Mean Total Score 230 minutes	30.28 Units on a scale Standard Error 1.31	30.33 Units on a scale Standard Error 1.2
Brief Psychiatric Rating Scale (BPRS) Mean Total Score Day 1	29.88 Units on a scale Standard Error 1.31	30.44 Units on a scale Standard Error 1.2
Brief Psychiatric Rating Scale (BPRS) Mean Total Score Day 21	30.93 Units on a scale Standard Error 1.39	32.1 Units on a scale Standard Error 1.2

SECONDARY outcome

Timeframe: 230 minutes, 1, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

The Young Mania Rating Scale (YMRS) mean total score at 230 minutes, 1 and 21 days following the first treatment administration. The YMRS is an 11-item clinician-rated scale that evaluates symptoms of mania or hypomania in adults. Each item is rated on scale from either 0-4 or 0-8, where 0 indicates a symptom is not present, and the highest score (4 or 8) indicates a symptom is extremely severe, with a total score range between 0 and 60. Higher scores indicate more severe manic/hypomanic symptoms. For each crossover period, the YMRS was completed 1440 minutes (24 hours) before intervention (baseline) and 230 minutes, 1 and 21 days following the first dose. Estimated marginal total score means were calculated using a linear mixed model regression that controlled for baseline and allowed treatment differences to vary by time point.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
The Young Mania Rating Scale (YMRS) Total Score Day 21	1.94 Units on a scale Standard Error 0.76	1.66 Units on a scale Standard Error 0.53
The Young Mania Rating Scale (YMRS) Total Score 230 minutes	2.08 Units on a scale Standard Error 0.72	1.77 Units on a scale Standard Error 0.53
The Young Mania Rating Scale (YMRS) Total Score Day 1	2.88 Units on a scale Standard Error 0.72	1.33 Units on a scale Standard Error 0.53

SECONDARY outcome

Timeframe: 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Number of participants with suicide ideation assessed using the Columbia Suicide Severity Rating Scale (CSSRS) ideation score. The CSSRS is administered as a structured clinical interview, and a participant's responses to screening items determine which subsequent items are administered. CSSRS ideation scores can range from 0 to 5. Due to skew, CSSRS total score was dichotomized so that score of 0 indicated no suicidal ideation and score ≥1 indicated the presence of suicidal ideation. For each crossover period, the CSSRS was completed one day before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Number of Participants With Suicide Ideation Assessed Using the Columbia Suicide Severity Rating Scale (CSSRS) 230 minutes	2 Participants	2 Participants
Number of Participants With Suicide Ideation Assessed Using the Columbia Suicide Severity Rating Scale (CSSRS) Day 1	2 Participants	2 Participants
Number of Participants With Suicide Ideation Assessed Using the Columbia Suicide Severity Rating Scale (CSSRS) Day 2	3 Participants	1 Participants
Number of Participants With Suicide Ideation Assessed Using the Columbia Suicide Severity Rating Scale (CSSRS) Day 3	2 Participants	1 Participants
Number of Participants With Suicide Ideation Assessed Using the Columbia Suicide Severity Rating Scale (CSSRS) Day 7	2 Participants	2 Participants
Number of Participants With Suicide Ideation Assessed Using the Columbia Suicide Severity Rating Scale (CSSRS) Day 14	2 Participants	3 Participants
Number of Participants With Suicide Ideation Assessed Using the Columbia Suicide Severity Rating Scale (CSSRS) Day 21	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose for each intervention period

Population: Analyses based on the intent-to-treat (ITT) population and included all randomized participants who had at least one post-baseline assessment.

Number of participants with suicide ideation assessed using the Scale for Suicide Ideation (SSI). SSI measures current suicidal ideation and behavior administered as a structured clinical interview, and a participant's responses to screening items determine which subsequent items are asked. A participant is asked from 5 and up to 21 items with each item rated on the scale of 0 to 2. Total scores range between 0 to 42. Due to skew, SSI total score was dichotomized so that score ≤1 indicated no suicidal ideation and score ≥2 indicated the presence of suicidal ideation. For each crossover period, the SSI was completed one day before intervention (baseline) and 230 minutes, 1, 2, 3, 7, 14, and 21 days following the first dose.

Outcome measures

Measure	TS-161 n=10 Participants Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 Participants Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Number of Participants With Suicide Ideation Assessed Using the Scale for Suicidal Ideation (SSI) Day 3	3 Participants	4 Participants
Number of Participants With Suicide Ideation Assessed Using the Scale for Suicidal Ideation (SSI) Day 7	3 Participants	3 Participants
Number of Participants With Suicide Ideation Assessed Using the Scale for Suicidal Ideation (SSI) 230 minutes	2 Participants	3 Participants
Number of Participants With Suicide Ideation Assessed Using the Scale for Suicidal Ideation (SSI) Day 1	2 Participants	4 Participants
Number of Participants With Suicide Ideation Assessed Using the Scale for Suicidal Ideation (SSI) Day 2	2 Participants	3 Participants
Number of Participants With Suicide Ideation Assessed Using the Scale for Suicidal Ideation (SSI) Day 14	3 Participants	4 Participants
Number of Participants With Suicide Ideation Assessed Using the Scale for Suicidal Ideation (SSI) Day 21	3 Participants	4 Participants

Adverse Events

TS-161

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TS-161 n=11 participants at risk Participants with major depressive disorder (MDD) were randomized to receive TS-161 100mg capsule orally once per day for three weeks (with option to decrease to 50 mg due to drug intolerance).	Placebo n=9 participants at risk Participants with major depressive disorder (MDD) were randomized to receive Placebo capsule orally once per day for three weeks.
Cardiac disorders Chest pain	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Cardiac disorders Tachycardia	9.1% 1/11 • Up to 16 weeks from start of study	22.2% 2/9 • Up to 16 weeks from start of study
Eye disorders Visual impairment	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Gastrointestinal disorders Diarrhoea	9.1% 1/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Gastrointestinal disorders Dry mouth	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Gastrointestinal disorders Faeces soft	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Gastrointestinal disorders Flatulence	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Gastrointestinal disorders Hiccups	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Gastrointestinal disorders Nausea	27.3% 3/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
General disorders Energy increased	0.00% 0/11 • Up to 16 weeks from start of study	22.2% 2/9 • Up to 16 weeks from start of study
General disorders Fatigue	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
General disorders Feeling of body temperature change	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Metabolism and nutrition disorders Decreased appetite	36.4% 4/11 • Up to 16 weeks from start of study	22.2% 2/9 • Up to 16 weeks from start of study
Musculoskeletal and connective tissue disorders Muscle rigidity	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Musculoskeletal and connective tissue disorders Muscle spasms	9.1% 1/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Musculoskeletal and connective tissue disorders Rectal tenesmus	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Nervous system disorders Abnormal dreams	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Nervous system disorders Aphasia	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Nervous system disorders Dizziness	45.5% 5/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Nervous system disorders Headache	9.1% 1/11 • Up to 16 weeks from start of study	22.2% 2/9 • Up to 16 weeks from start of study
Nervous system disorders Hypersomnia	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Nervous system disorders Somnolence	18.2% 2/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Nervous system disorders Vertigo	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Psychiatric disorders Anxiety	18.2% 2/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Psychiatric disorders Derealisation	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Psychiatric disorders Distractibility	9.1% 1/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Psychiatric disorders Euphoric mood	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Psychiatric disorders Irritability	0.00% 0/11 • Up to 16 weeks from start of study	22.2% 2/9 • Up to 16 weeks from start of study
Renal and urinary disorders Dysuria	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Renal and urinary disorders Pollakiuria	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Reproductive system and breast disorders Pelvic discomfort	9.1% 1/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study
Skin and subcutaneous tissue disorders Tinea pedis	0.00% 0/11 • Up to 16 weeks from start of study	11.1% 1/9 • Up to 16 weeks from start of study
Vascular disorders Hypotension	18.2% 2/11 • Up to 16 weeks from start of study	0.00% 0/9 • Up to 16 weeks from start of study

Additional Information

Zarate, Carlos

National Institute of Mental Health

Phone: +1 301 451 0861

Email: zaratec@mail.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place