A Phase 3 interventional study of NEST-1 (NeoSync EEG Synchronized TMS) and SHAM in Major Depressive Disorder, sponsored by Wave Neuroscience. Completed at 18 sites in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-26.
Sponsored by Wave Neuroscience · Phase 3, Interventional, and Treatment
This study is designed to evaluate the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Major Depressive Disorder. This is a multicenter study in which subjects will be randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy or antidepressant medications during the follow-up phase of the study. Follow-up evaluation visits will be conducted during those four weeks, with the frequency of the visits determined by the treatment choice during that timeframe.
Major Depressive Disorder (MDD) is a mental disorder associated with significant functional impairment and disability. Affected individuals present with depressed mood, loss of interest or pleasure, feelings of guilt, low self-worth, disturbed sleep or appetite, low energy, and poor concentration.
Psychopharmacological therapy as today's mainstream treatment has revolutionized the clinical management for major depressive disorders and has been shown to improve the quality of life for many patients. With that, these therapies are not effective for all patients. Results released from the Sequenced Treatment Alternatives to Relieve Depression Study (STAR*D), conducted by the National Institute of Mental Health (NIMH), show that approximately 30% of depressed subjects respond to an SSRI in their first trial, despite adequate dosing and duration of treatment. The SSRI antidepressants do have a more favorable side effect profile than older medications, but they still may be difficult for some patients to tolerate because of gastrointestinal distress, anxiety, insomnia, and sexual dysfunction.
In addition to the psychopharmacologic treatments for depression, other therapies such as electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS) have been shown to have a therapeutic effect in MDD. ECT induces seizures electrically in anesthetized subjects. It is generally safe and effective; however the procedure can have the negative side effect of memory loss and confusion. Treatment with repetitive stimulation (rTMS) is intended to stimulate groups of cells in areas of the brain linked to MDD. While the therapy is non-invasive, it is expensive, involves a complex method for locating the point of stimulation in the brain, and has the potential for seizures.
rTMS uses magnetic pulses which causes neuronal activation of specific areas in the brain. It is generally believed that this activation causes resetting of cortical oscillators to create a therapeutic effect in MDD. The investigators hypothesize that TMS using low energy, sinusoidal magnetic fields synchronized to a patient's individual alpha frequency,(sTMS), can also affect neuronal activity leading to a reemergence of intrinsic rhythms and clinical improvement in MDD. Preliminary study results using sTMS have shown improvements in depressive symptoms with minimal side effects.
This multicenter study is designed to evaluate the safety and efficacy of sTMS in subjects with Major Depressive Disorder. Subjects will be randomized to receive treatment 5 days per week for 6 weeks. At the end of Treatment Week 6, subject will have completed the study treatments and will be offered open label sTMS therapy or alternate antidepressant treatment as clinically indicated. At minimum, subjects will be asked to return for one follow-up visit four weeks after their last double-blind treatment (Week 10) for evaluation and study completion.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 202 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Wave Neuroscience is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnosed with the following conditions (current unless otherwise stated):
Subjects with a clinically defined neurological disorder including, but not limited to:
Subjects with any of the following treatment histories:
Significant acute suicide risk, defined as:
Treatment with the NEST-1 Device
Device: NEST-1 (NeoSync EEG Synchronized TMS)
Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
Device: SHAM
The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.
The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Mean HAM-D17 Total Score Change (Intent to Treat - All)
The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. If any subject did not complete the double-blind phase in the ITT population, the assessment last observation carried forward (LOCF) was used. The single value provided in each arm reflects the change seen. For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.
Time frame: Baseline to End of Double-Blind Treatment Period (Week 6)
Mean HAM-D17 Total Score Change (Per Protocol - All)
The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to the HAM-D17 total score at Week 6. The single value provided in each arm reflects the change seen. For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.
Time frame: Baseline to End of Double-Blind Treatment Period (Week 6)
Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects)
All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to Week 6 HAM-D17 total score. The single value provided in each arm reflects this change. This analysis included only Per Protocol subjects exposed to an antidepressant medication in their current episode (non-naive). This includes past history of intolerance, resistance, or inadequate dosing/duration. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.
Time frame: Baseline to End of Double-Blind Treatment Period (Week 6)
Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat)
For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. If any subject did not complete the double-blind phase (Week 6) in the ITT population, the assessment last observation carried forward (LOCF) was used. This outcome provides the total number of subjects in each arm that achieved clinical response within the Intent to Treat population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
Time frame: Baseline to End of Double-Blind Treatment Period (Week 6)
Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All)
For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol population completed Week 6. This outcome provides the total number of subjects in each arm that achieved clinical response within the Per Protocol population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
Time frame: Baseline to End of Double-Blind Treatment Period (Week 6)
Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects)
The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response, defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol (PP) population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive). This outcome provides the total number of subjects in each arm that achieved clinical response within the Non-Naive, Per Protocol population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
Time frame: Baseline to End of Double-Blind Treatment Period (Week 6)
Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat)
The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. If any subject did not complete the double-blind phase (Week 6) in the Intent to Treat (ITT) population, the assessment last observation carried forward (LOCF) was used. This outcome provides the total number of subjects in each arm that achieved clinical remission within the ITT population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
Time frame: Baseline to End of Double-Blind Treatment Period (Week 6)
Number of Subjects Who Demonstrate Clinical Remission at Week 6 (Per Protocol - All)
For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This outcome provides the total number of subjects in each arm that achieved clinical remission within the Per Protocol population at Week 6. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
Time frame: Baseline to End of Double-Blind Treatment Period (up to week 6)
Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Per Protocol - Non-Naive Subjects)
The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive). This outcome provides the total number of subjects in each arm that achieved clinical remission at Week 6 within the Non-Naive, Per Protocol population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
Time frame: Baseline to End of Double-Blind Treatment Period (Week 6)
Enrollment occurred across 17 study sites (both academic and private clinical locations), initiated in May 2012 and all subject visits complete by July 2013. Three sites discontinued early due to departure of the Principal Investigator or due to a loss of contributing staff personnel. None were discontinued specifically due to a lack of enrollment.
| Milestone | Active sTMS | Sham |
|---|---|---|
| Started | 103 | 99 |
| Completed | 86 | 77 |
| Not completed | 17 | 22 |
| Withdrew: Withdrawal by subject | 8 | 8 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Adverse event | 2 | 4 |
| Withdrew: Lack of efficacy | 3 | 5 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Protocol violation | 1 | 3 |
The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. If any subject did not complete the double-blind phase in the ITT population, the assessment last observation carried forward (LOCF) was used. The single value provided in each arm reflects the change seen. For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.
| units on a scale | Active sTMS | Sham |
|---|---|---|
| Mean HAM-D17 Total Score Change (Intent to Treat - All) | -7.49 ± 7.25 | -6.97 ± 6.28 |
The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to the HAM-D17 total score at Week 6. The single value provided in each arm reflects the change seen. For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.
| units on a scale | Active sTMS | Sham |
|---|---|---|
| Mean HAM-D17 Total Score Change (Per Protocol - All) | -9.00 ± 6.54 | -6.56 ± 5.85 |
All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to Week 6 HAM-D17 total score. The single value provided in each arm reflects this change. This analysis included only Per Protocol subjects exposed to an antidepressant medication in their current episode (non-naive). This includes past history of intolerance, resistance, or inadequate dosing/duration. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.
| units on a scale | Active sTMS | Sham |
|---|---|---|
| Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects) | -8.58 ± 6.93 | -4.25 ± 4.75 |
For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. If any subject did not complete the double-blind phase (Week 6) in the ITT population, the assessment last observation carried forward (LOCF) was used. This outcome provides the total number of subjects in each arm that achieved clinical response within the Intent to Treat population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
| participants | Active sTMS | Sham |
|---|---|---|
| Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat) | 27 | 25 |
For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol population completed Week 6. This outcome provides the total number of subjects in each arm that achieved clinical response within the Per Protocol population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
| participants | Active sTMS | Sham |
|---|---|---|
| Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All) | 20 | 18 |
The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response, defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol (PP) population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive). This outcome provides the total number of subjects in each arm that achieved clinical response within the Non-Naive, Per Protocol population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
| participants | Active sTMS | Sham |
|---|---|---|
| Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects) | 13 | 3 |
The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. If any subject did not complete the double-blind phase (Week 6) in the Intent to Treat (ITT) population, the assessment last observation carried forward (LOCF) was used. This outcome provides the total number of subjects in each arm that achieved clinical remission within the ITT population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
| participants | Active sTMS | Sham |
|---|---|---|
| Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat) | 11 | 14 |
For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This outcome provides the total number of subjects in each arm that achieved clinical remission within the Per Protocol population at Week 6. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
| participants | Active sTMS | Sham |
|---|---|---|
| Number of Subjects Who Demonstrate Clinical Remission at Week 6 (Per Protocol - All) | 9 | 10 |
The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive). This outcome provides the total number of subjects in each arm that achieved clinical remission at Week 6 within the Non-Naive, Per Protocol population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
| participants | Active sTMS | Sham |
|---|---|---|
| Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Per Protocol - Non-Naive Subjects) | 5 | 2 |
Collected over All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active sTMS | — | 2/103 (1.9%) | 80/103 (77.7%) |
| Sham | — | 1/99 (1%) | 42/99 (42.4%) |
| Event | Active sTMS | Sham |
|---|---|---|
| Hospitalization (Suicide Attempt)Psychiatric disorders | 0/103 | 1/99 |
| Hospitalization (Risk of Self Harm)Psychiatric disorders | 1/103 | 0/99 |
| Hospitalization (Dehydration)Gastrointestinal disorders | 1/103 | 0/99 |
| Event | Active sTMS | Sham |
|---|---|---|
| HeadacheNervous system disorders | 22/103 | 19/99 |
| Back PainMusculoskeletal and connective tissue disorders | 9/103 | 4/99 |
| InsomniaPsychiatric disorders | 7/103 | 5/99 |
| Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 7/103 | 5/99 |
| Non-Specific GI DiscomfortGastrointestinal disorders | 4/103 | 3/99 |
| Leg and Foot PainMusculoskeletal and connective tissue disorders | 4/103 | 0/99 |
| AgitationNervous system disorders | 4/103 | 1/99 |
| DizzinessNervous system disorders | 4/103 | 2/99 |
| ParesthesiaNervous system disorders | 4/103 | 0/99 |
| TinnitusEar and labyrinth disorders | 3/103 | 1/99 |
| Age, Continuous(years) | Active sTMS | Sham | Total |
|---|---|---|---|
| Mean | 46.1 ± 11.3 | 45.7 ± 12.2 | 45.9 ± 11.7 |
| Sex: Female, Male(Participants) | Active sTMS | Sham | Total |
|---|---|---|---|
| Female | 62 | 66 | 128 |
| Male | 41 | 33 | 74 |
| Race/Ethnicity, Customized(participants) | Active sTMS | Sham | Total |
|---|---|---|---|
| American Indian / Alaskan Native | 0 | 2 | 2 |
| Asian | 5 | 3 | 8 |
| Black or African American | 6 | 8 | 14 |
| Hispanic or Latino | 6 | 6 | 12 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| White | 82 | 79 | 161 |
| Other or Unknown | 3 | 1 | 4 |
| Region of Enrollment(participants) | Active sTMS | Sham | Total |
|---|---|---|---|
| United States | 103 | 99 | 202 |
| Baseline Mean Hamilton Rating Scale for Depression (HAM-D17)(units on a scale) | Active sTMS | Sham | Total |
|---|---|---|---|
| Mean | 21.94 ± 3.46 | 21.15 ± 3.25 | 21.55 ± 3.37 |
| Length of Current Episode in Months(months) | Active sTMS | Sham | Total |
|---|---|---|---|
| Mean | 10.9 ± 6.8 | 10.8 ± 6.7 | 10.85 ± 6.73 |
| Antidepressant Exposure in Current Episode(participants) | Active sTMS | Sham | Total |
|---|---|---|---|
| Inadequate Dose/Duration of >= 1 Medication | 11 | 13 | 24 |
| Intolerant of >= 1 Medication | 10 | 5 | 15 |
| Treatment Naive (ATHF 0) | 40 | 37 | 77 |
| Adequate Trial of >= 1 Medication | 61 | 65 | 126 |
| Education Level(participants) | Active sTMS | Sham | Total |
|---|---|---|---|
| Some high school or less | 2 | 1 | 3 |
| High school diploma | 19 | 7 | 26 |
| Vocational school | 1 | 2 | 3 |
| Some college | 17 | 31 | 48 |
| College degree | 42 | 42 | 84 |
| Professional or Graduate degree | 21 | 15 | 36 |
| Unknown | 1 | 1 | 2 |
The record gives a start of May 2012, a primary completion of Aug 2013 and a completion of Sep 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2015, 1 year 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wave Neuroscience