Clinical trial NCT01415154: Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder
Official title: A 12-Month Prospective Randomized Dual-Arm Pilot Study of Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: TMS
Major Depressive Disorder
NeuroStar TMS
Lead sponsor: Neuronetics
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic worsening in patients who have shown a clinical response to acute TMS treatment.

Detailed description: This is a 12-month maintenance treatment study for patients who have responded to a 6 week course of acute TMS treatment for major depressive disorder (MDD). The study will seek to assess the change in depressive symptomatology across the duration of maintenance treatment using observer and self-administered efficacy measures. Describe the efficacy of TMS re-introduction in patients not receiving maintenance pharmacotherapy who show a recurrence of depressive symptoms. Assess the safety and durability of acute TMS therapy followed by maintenance TMS treatment for up to 12 months.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single episode or recurrent course of illness, with the additional stipulation of a duration for this episode of ≥ 4 weeks and CGI-S ≥ 4.
* Duration of current episode of depression ≤ 3 years (the definition of an episode is demarcated by a period of ≥ 2 months when the patient did not meet full criteria for the DSM-IV definition of Major Depressive Episode.
* Capable and willing to provide informed consent.
* Signed HIPAA authorization.
* Able to adhere with the treatment schedule, and withdrawal of ongoing pharmacotherapy.
* If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.

Exclusion Criteria:

* Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
* Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):

  * Depression secondary to a general medical condition, or substance- induced;
  * Seasonal pattern of depression as defined by DSM-IV;
  * History of substance abuse or dependence within the past year except nicotine and caffeine);
  * Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes;
  * Bipolar disorder;
  * Eating disorder (current or within the past year);
  * Obsessive compulsive disorder (lifetime); or
  * Post-traumatic stress disorder (current or within the past year).
* An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol.
* Individuals with a clinically defined neurological disorder or insult including, but not limited to:

  * Any condition likely to be associated with increased intracranial pressure;
  * Space occupying brain lesion;
  * History of cerebrovascular accident;
  * Transient ischemic attack within two years;
  * Cerebral aneurysm;
  * Dementia;
  * Parkinson's disease;
  * Huntington's chorea;
  * Multiple sclerosis.
* Increased risk of seizure for any reason, including but not limited to prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for ≥ 5 minutes.
* History of treatment with Vagus Nerve Stimulation.
* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.

Primary outcomes:
measure: Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.
timeFrame: 12 month evaluation
Secondary outcomes:
measure: Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms.
timeFrame: 12 Month evaluation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Lincoln
country: United States
facility: Premier Psychiatric Group, L.L.C.
state: Nebraska
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Mercer Island
country: United States
facility: Center for Anxiety and Depression
state: Washington
Study officials:
affiliation: Neuronetics
name: David G. Brock, MD
role: STUDY_DIRECTOR
References: