---
title: A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
nct_id: NCT01909232
overall_status: COMPLETED
phase: NA
sponsor: Cervel Neurotech, Inc.
study_type: INTERVENTIONAL
primary_condition: Depressive Disorder, Major
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01909232.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01909232"
ct_last_update_post_date: 2016-07-28
last_seen_at: "2026-05-12T06:37:07.814Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)

**Official Title:** A Prospective, Double-Blind, Randomized, Parallel-Group, Sham-Controlled Feasibility Trial of Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder

**NCT ID:** [NCT01909232](https://clinicaltrials.gov/study/NCT01909232)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 92
- **Lead Sponsor:** Cervel Neurotech, Inc.
- **Conditions:** Depressive Disorder, Major
- **Start Date:** 2013-07
- **Completion Date:** 2014-07
- **CT.gov Last Update:** 2016-07-28

## Brief Summary

The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Current major depressive disorder (MDD)
* Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode
* On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study
* Weight less than 350 pounds

Exclusion Criteria:

* Current major depressive disorder episode of more than three years
* Seizure disorder
* History of brain injury, stroke or active central nervous system disease
* Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe
* Active suicidal intent or plan
* Other significant psychiatric disorder
* Alcohol or substance dependence or abuse
* Prior treatment with transcranial magnetic stimulation
* Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation
* If female, pregnant or lactating or planning to become pregnant within the next three months
```

## Arms

- **Active rTMS treatment** (EXPERIMENTAL) — Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
- **Sham rTMS treatment** (SHAM_COMPARATOR) — Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

## Interventions

- **Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator** (DEVICE) — The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils.
- **Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator** (DEVICE) — The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.

## Primary Outcomes

- **Change in depression severity** _(time frame: Baseline to four weeks (the conclusion of rTMS treatment))_ — Measured by the 24-item Hamilton Rating Scale for Depression

## Secondary Outcomes

- **Change in depression severity** _(time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))_
- **Clinically significant response** _(time frame: Baseline to four weeks (the conclusion of rTMS treatment))_
- **Clinically significant response** _(time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))_
- **Remission from depression** _(time frame: Baseline to four weeks (the conclusion of rTMS treatment))_
- **Remission from depression** _(time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))_
- **Change in quality of life** _(time frame: Baseline to four weeks (the conclusion of rTMS treatment))_
- **Change in quality of life** _(time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))_
- **Incidence of treatment-emergent adverse events and serious adverse events** _(time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))_

## Locations (6)

- Emory University, Atlanta, Georgia, United States
- Sheppard-Pratt Health System, Baltimore, Maryland, United States
- Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
- Kaiser Permanente Center for Health Research, Portland, Oregon, United States
- Butler Hospital, Providence, Rhode Island, United States
- CRI Lifetree, Salt Lake City, Utah, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.emory university|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.sheppard-pratt health system|baltimore|maryland|united states` — added _(2026-05-12)_
- `locations.dartmouth-hitchcock medical center|lebanon|new hampshire|united states` — added _(2026-05-12)_
- `locations.kaiser permanente center for health research|portland|oregon|united states` — added _(2026-05-12)_
- `locations.butler hospital|providence|rhode island|united states` — added _(2026-05-12)_
- `locations.cri lifetree|salt lake city|utah|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01909232.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01909232*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*