Trial Outcomes & Findings for Transcranial Magnetic Stimulation (TMS) in Obsessive Compulsive Disorder (OCD): Mechanisms and Biomarkers (NCT NCT02355002)

Last Updated: 2026-02-13

Results Overview

The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the gold-standard, semi-structured clinician-administered assessment of OCD symptom severity. It contains 10 items ranging from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. Higher scores indicate more severe OCD symptom severity. We compared the efficacy of TMS to Sham in reducing OCD symptom severity over a 6-week period. Efficacy was again compared in the follow-up phase of the study in from week 6 to week 18.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

Change in YBOCS from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.

Results posted on

2026-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Active Transcranial Magnetic Stimulation (TMS) Treatment In this arm subjects will receive real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.	Sham-TMS Treatment This arm serves as the sham/placebo control. In TMS a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.
Period 1: Phase 1, Randomized-Controlled STARTED	15	11
Period 1: Phase 1, Randomized-Controlled COMPLETED	12	10
Period 1: Phase 1, Randomized-Controlled NOT COMPLETED	3	1
Period 2: Phase 2 Open-Label STARTED	16	0
Period 2: Phase 2 Open-Label COMPLETED	12	0
Period 2: Phase 2 Open-Label NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Transcranial Magnetic Stimulation (TMS) Treatment In this arm subjects will receive real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.	Sham-TMS Treatment This arm serves as the sham/placebo control. In TMS a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.
Period 1: Phase 1, Randomized-Controlled Protocol Violation	1	0
Period 1: Phase 1, Randomized-Controlled Adverse Event	1	0
Period 1: Phase 1, Randomized-Controlled Withdrawn by principal investigator due to start of the COVID-19 lock-down	1	0
Period 1: Phase 1, Randomized-Controlled Lost to Follow-up	0	1
Period 2: Phase 2 Open-Label Withdrawal by Subject	2	0
Period 2: Phase 2 Open-Label Participant left country	1	0
Period 2: Phase 2 Open-Label Withdrawn by principal investigator due to start of the COVID-19 lock-down	1	0

Baseline Characteristics

Transcranial Magnetic Stimulation (TMS) in Obsessive Compulsive Disorder (OCD): Mechanisms and Biomarkers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Transcranial Magnetic Stimulation (TMS) Treatment n=15 Participants In this arm subjects will receive real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.	Sham-TMS Treatment n=11 Participants This arm serves as the sham/placebo control. In TMS a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=6 Participants	11 Participants n=6 Participants	26 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Sex: Female, Male Female	9 Participants n=6 Participants	5 Participants n=6 Participants	14 Participants n=12 Participants
Sex: Female, Male Male	6 Participants n=6 Participants	6 Participants n=6 Participants	12 Participants n=12 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=12 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Race (NIH/OMB) White	13 Participants n=6 Participants	7 Participants n=6 Participants	20 Participants n=12 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=12 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants
Region of Enrollment United States	15 participants n=6 Participants	11 participants n=6 Participants	26 participants n=12 Participants

PRIMARY outcome

Timeframe: Change in YBOCS from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.

Population: Number Analyzed in Row Differs Due to Missing/Incomplete Data

Outcome measures

Outcome measures
Measure	Active Transcranial Magnetic Stimulation (TMS) Treatment n=15 Participants In this arm subjects will receive real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.	Sham-TMS Treatment n=11 Participants This arm serves as the sham/placebo control. In TMS a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.
Obsessive Compulsive Symptoms as Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Week 0	23.9 score on a scale Standard Deviation 4.2	23.1 score on a scale Standard Deviation 4.1
Obsessive Compulsive Symptoms as Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Week 6	23.23 score on a scale Standard Deviation 4.4	20.6 score on a scale Standard Deviation 5.5
Obsessive Compulsive Symptoms as Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Week 18	23.5 score on a scale Standard Deviation 3.5	17.0 score on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: Change in OBQ from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.

Population: Number Analyzed in Row Differs Due to Missing/Incomplete Data

The Obsessive-Compulsive Beliefs Questionnaire (OBQ) is a patient-rated assessment of beliefs considered important in the development and maintenance of obsessive-compulsive disorder (OCD). It contains 44 items ranging from 1 (disagree very much) to 7 (agree very much) across 3-4 thought domains, yielding a total possible score range from 44 to 308. Higher scores indicate more strongly held OCD-related beliefs. We compared the efficacy of TMS to Sham in reducing OCD beliefs over a 6-week period. Efficacy was again compared in the follow-up phase of the study in from week 6 to week 18.

Outcome measures

Outcome measures
Measure	Active Transcranial Magnetic Stimulation (TMS) Treatment n=15 Participants In this arm subjects will receive real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.	Sham-TMS Treatment n=11 Participants This arm serves as the sham/placebo control. In TMS a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.
Obsessive Compulsive Beliefs as Measured by Obsessive-Compulsive Beliefs Questionnaire (OBQ) Week 0	186.53 score on a scale Standard Deviation 53.29	178.91 score on a scale Standard Deviation 33.15
Obsessive Compulsive Beliefs as Measured by Obsessive-Compulsive Beliefs Questionnaire (OBQ) Week 6	190.60 score on a scale Standard Deviation 63.55	180.30 score on a scale Standard Deviation 36.90
Obsessive Compulsive Beliefs as Measured by Obsessive-Compulsive Beliefs Questionnaire (OBQ) Week 18	220.00 score on a scale Standard Deviation 73.54	147.00 score on a scale Standard Deviation 89.10

SECONDARY outcome

Timeframe: Change in OCI from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.

Population: Number Analyzed in Row Differs Due to Missing/Incomplete Data

The Obsessive Compulsive Inventory-Revised (OCI-R) is a self-report questionnaire that measures OCD symptoms across 6 sub-scales including washing, checking, neutralizing, obsessing, ordering and hoarding. It contains 18 items ranging from 0 (not at all) to 4 (extremely), yielding a total possible score range from 0 to 72. Higher scores indicate more severe OCD symptoms. We compared the efficacy of TMS to Sham in reducing inventory of obsessive symptoms over a 6-week period. Efficacy was again compared in the follow-up phase of the study in from week 6 to week 18.

Outcome measures

Outcome measures
Measure	Active Transcranial Magnetic Stimulation (TMS) Treatment n=15 Participants In this arm subjects will receive real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.	Sham-TMS Treatment n=11 Participants This arm serves as the sham/placebo control. In TMS a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.
Total Number of Obsessive Symptoms is Reduced as Measured by Obsessive-Compulsive Inventory Questionnaire (OCI)-Revised Week 0	26.27 score on a scale Standard Deviation 11.21	31.20 score on a scale Standard Deviation 14.05
Total Number of Obsessive Symptoms is Reduced as Measured by Obsessive-Compulsive Inventory Questionnaire (OCI)-Revised Week 6	31.00 score on a scale Standard Deviation 12.32	24.70 score on a scale Standard Deviation 11.40
Total Number of Obsessive Symptoms is Reduced as Measured by Obsessive-Compulsive Inventory Questionnaire (OCI)-Revised Week 18	30.50 score on a scale Standard Deviation 10.61	15.50 score on a scale Standard Deviation 19.09

Adverse Events

Active Transcranial Magnetic Stimulation (TMS) Treatment (Phase I)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham-TMS Treatment (Phase I)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Open-label Active Transcranial Magnetic Stimulation (TMS) Treatment (Phase II)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Drs. Joan Camprodon and Sabine Wilhelm

Massachusetts General Hospital

Phone: 6177265340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active Transcranial Magnetic Stimulation (TMS) Treatment (Phase I) n=15 participants at risk In this arm participants received real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.	Sham-TMS Treatment (Phase I) n=11 participants at risk This arm served as the sham/placebo control. In TMS, a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.	Open-label Active Transcranial Magnetic Stimulation (TMS) Treatment (Phase II) n=16 participants at risk In this arm subjects received real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.
Musculoskeletal and connective tissue disorders Herniated Disk in Back	0.00% 0/15 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	6.2% 1/16 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Ear and labyrinth disorders Ear Pain/Pressure	6.7% 1/15 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Injury, poisoning and procedural complications Minor Car Accident	6.7% 1/15 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Psychiatric disorders OCD Symptom Worsening	13.3% 2/15 • Number of events 2 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Respiratory, thoracic and mediastinal disorders Flu-Like Symptoms	6.7% 1/15 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Psychiatric disorders Panic Attack	6.7% 1/15 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Musculoskeletal and connective tissue disorders Sharp Pain in Neck	6.7% 1/15 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Nervous system disorders Headaches	13.3% 2/15 • Number of events 2 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Psychiatric disorders Increased Irritability	0.00% 0/15 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	6.2% 1/16 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Nervous system disorders Fatigue After TMS	0.00% 0/15 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	6.2% 1/16 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Psychiatric disorders Increased Anxiety	13.3% 2/15 • Number of events 2 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Psychiatric disorders Hypomanic Episode	6.7% 1/15 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Psychiatric disorders Increased Depressive Symptoms	6.7% 1/15 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	6.2% 1/16 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Gastrointestinal disorders Nausea Following MRI	0.00% 0/15 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	9.1% 1/11 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Nervous system disorders Pre-Syncopal Epsiode	0.00% 0/15 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	9.1% 1/11 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Gastrointestinal disorders Stomach Bug	6.7% 1/15 • Number of events 1 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/11 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.	0.00% 0/16 • Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.