rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II

NCT00447096 | Withdrawn Phase 2

• 1 other identifier: 102006-040
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This research study evaluates an experimental device for the treatment of the depressed phase of Bipolar Disorder Type II. Repetitive Transcranial Magnetic Stimulation (rTMS) is an experimental procedure where a device delivers an alternating magnetic field to a focal area of the brain. When the coil is placed against the scalp on the left frontal area of the head, the magnetic field is focused to a region of the brain that is thought to be involved in depression. This study is intended to test if rTMS can affect this region of the brain in a way that improves the symptoms of depression related to Bipolar Disorder Type II. The purpose of this study is to obtain safety and efficacy information regarding the use of rTMS(Repetitive Transcranial Magnetic Stimulation) for patients in the depressed phase of Bipolar Disorder Type II.

Conditions

Bipolar Disorder

Keywords

Bipolar Type II; Depression; rTMS

Outcome Measures

Primary Outcomes (1)

• QIDS-C (Quick Inventory of Depressive Symptomatology-Clinical Rated)

  3 year

Secondary Outcomes (6)

• MADRS(Montgomery Asberg Depression Rating Scale)

  3 year

• IDS-C (Inventory of Depressive Symptomatology- Clinician Rated)

  3 year

• QIDS-SR (Quick Inventory of Depressive Symptomatology-Self Report)

  3 year

• YMRS (Young Mania Rating Scale)

  3 year

• Neuropsychological Testing

  3 year

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Treatment arm will receive treatment 5 days a week for 6 weeks. Repetitive transcranial magnetic stimulation (rTMS) treatment.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham Arm

SHAM COMPARATOR

Sham Arm will not receive any stimulation 5 days a week for 6 weeks. Sham transcranial magnetic stimulation.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

Repetitive transcranial magnetic stimulation (rTMS).

Sham Arm; Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female outpatients aged 18-55 years old
• Meet DSM-IV criteria for Bipolar Affective Disorder Type II, depressed phase without psychosis as determined by Structured Clinical Interview for DSM-IV
• A MADRS ≥ 15 at Initial Visit, and at Prior to TMS Evaluation
• A Young Mania Rating Scale \< 12 at Initial Visit and at Prior to TMS Evaluation
• Duration of current episode of depression \>2 months but ≤ 1 year of unsuccessful treatment
• On stable medication and/or psychotherapy for 1 month and clinically appropriate to maintain for duration of trial
• Cognitively intact (Folstein MMSE score \>24).
• Clinically competent to give informed written consent

You may not qualify if:

• History of epilepsy or seizure disorder, mass brain lesions, cerebrovascular accident, metal in the skull, a history of major head trauma, or any neurologic condition likely to increase risk of rTMS.
• Suicidal risk that precludes safe participation defined as score of 5 or 6 on MADRS item 10 Suicidal Thoughts or clinical impression that the subject is at significant risk for suicide.
• History of any DSM-IV Axis I diagnosis other than Bipolar Affective Disorder Type II, depressed phase, simple phobia and generalized anxiety disorder (GAD) in the last year
• Lifetime history of schizophrenia, schizoaffective, or other psychotic disorder, bipolar disorder type I, dementia, dissociative disorders, and sexual and gender identity disorder
• Personality disorder that makes participation in the trial difficult
• Greater than or equal to 8 episodes of mood disturbance in the previous 12 months
• Greater than 4 unsuccessful treatments in current episode
• History of Substance Abuse or Dependence (DSM-IV) in the last year except nicotine and caffeine
• Positive urine drug test during screening
• Taking any medication that significantly lowers the seizure threshold (e.g. lithium, stimulants, bupropion, TCAs, antipsychotics, theophylline, etc.)
• Unstable medical conditions that precludes safe participation in rTMS treatment trial
• Known or suspected pregnancy
• Women of child-bearing potential not using medically accepted form of contraception when engaged in sexual intercourse
• Any metal or device implants that would increase risk of rTMS
• Unable to determine the motor threshold in the subject

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Stanley Medical Research Institute: collaborator
• Neuronetics: collaborator

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• F. Andrew Kozel, MD, MSCR

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 14, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

US (1)