An Open Label Trial of TMS Therapy for Bipolar Depression

NCT02640950 | Completed Results

• 1 other identifier: 794736-5
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

Transcranial Magnetic Stimulation (TMS) is an increasingly accepted neurostimulation- based treatment for major depressive disorder. While there is a growing anecdotal database supporting its use in bipolar depression the investigators propose to collect open label efficacy and safety data in a small population of patients with clinically verified bipolar disorder.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (2)

• The Percentage of Patients Who Respond or Remit After 30 to 35 Treatments Based Off of the Montgomery-Åsberg Depression Rating Scale (MADRS)

  The MADRS is a clinician rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. A decrease in MADRS score of at lease 50% will be considered a response to treatment. A MADRS score of less than 10 will be considered remission.

  Up to 7 weeks

• The Percentage of Patients Who Meet Criteria for Onset of Manic Symptoms Based on the Young Mania Rating Scale (YMRS).

  The Young Mania Rating Scale (YMRS) is used to determine the severity of a patient's mania. The score for the YMRS ranges form 0 to 60. Scores of 13-19 indicate minimal manic symptoms, 20-25 is mild mania, 26-37 is moderate mania, and 38-60 is severe mania. A YMRS score of 14 or greater will be used for criteria of onset of manic symptoms. The patients will be separated based on their diagnostic category of either Bipolar I Disorder or Bipolar II Disorder.

  Up to 7 weeks

Secondary Outcomes (4)

• Hamilton Depression Rating Scale (HAM-D) to Calculate Percentage of Patients Meeting Response Criteria

  Up to 7 weeks

• Clinical Global Impression (CGI) to Calculate Percentage of Patients Meeting Response Criteria

  Up to 7 weeks and 6 Month Follow Up

• Hamilton Depression Rating Scale (HAM-D) to Average Number of Treatments Needed to Meet Remission

  7 Weeks

• Clinical Global Impression (CGI) to Calculate Average Number of Treatments Needed to Meet Remission

  7 Weeks

Study Arms (1)

Open-Label TMS

EXPERIMENTAL

Active Transcranial Magnetic Stimulation

Device: NeuroStar TMS

Interventions

NeuroStar TMS DEVICE

Transcranial Magnetic Stimulation

Also known as: Transcranial Magnetic Stimulation

Open-Label TMS

Eligibility Criteria

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

You may qualify if:

• Must be at least 18 years old.
• Must meet DSM-5 criteria for bipolar (either I or II) depression by clinical interview and M.I.N.I. The duration of the current depressive episode must be at least 4 weeks and no longer than 3 years in length.
• Should have a MADRS score of at least 20 at screening, an YMRS score of less than 12 and a CGI score of at least 4.
• Must have signed the informed consent document and have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.
• Must be on a mood stabilizer acceptable to the study physician which is consistent with their diagnosis. The mood stabilizer must be at a stable dose for at least four days before starting TMS treatment.
• If female of childbearing potential, patients must
• have a negative urine pregnancy test at screening, and
• not be nursing or planning a pregnancy, and
• be on a medically acceptable method of birth control acceptable to the principal investigator.
• Choices of contraception that meet the study requirements are
• Intrauterine device
• Hormonal contraception (estrogen-containing birth control pills, Vaginal ring, patch, injections or implants)
• Latex condom with spermicide
• Diaphragm with spermicide
• Cervical cap with spermicide

You may not qualify if:

• May not be directly affiliated with Sheppard Pratt Clinical Research Programs or be immediate family of Research Programs personnel.
• Must not have another primary Axis I diagnosis.
• The subject must not have stopped an antidepressant less than two weeks before starting TMS treatment or unable to discontinue antidepressant therapy.
• Should have no previous history of psychosis or substance dependence or abuse within the six months prior to Screening
• Presence of an Axis II disorder felt by the investigator to potentially interfere with study compliance would exclude a potential participant.
• Should not have prior intolerance of TMS or significant lack of response to adequate trials of TMS.
• Should not have a lifetime history of lack of response to ECT or VNS.
• Should not have any medical condition likely to interfere with safe study participation.
• Women of child-bearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse are excluded, as well as women who are pregnant or breast-feeding.
• Positive urine screen for any substance of abuse will exclude a patient, with the exception of benzodiazepines. A satisfactory explanation in the opinion of the investigator along with a negative repeat screen prior to Visit 2 is possibly acceptable.
• Current suicide risk, as evidenced:
• It is the judgment of the investigator that the patient may be at risk for suicide
• The patient has rated a "yes" to question 4 or question 5 on the Screening C-SSRS
• The patient has attempted suicide within the past 12 months prior to Screening.
• History of head injury, epilepsy or seizure disorder, non-removable metallic implants or objects in or around the head.

Sponsors & Collaborators

• Sheppard Pratt Health System: lead
• Mayo Clinic: collaborator

Study Sites (2)

Sheppard Pratt Health System

Baltimore, Maryland, 21204, United States

Location

Department of Psychiatry and Psychology, Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Aaronson ST, Goldwaser EL, Croarkin PE, Geske JR, LeMahieu A, Sklar JH, Kung S. A Pilot Study of High-Frequency Transcranial Magnetic Stimulation for Bipolar Depression. J Clin Psychiatry. 2024 May 20;85(2):23m15056. doi: 10.4088/JCP.23m15056.

  PMID: 38780536 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

Open label trial

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Sheppard Pratt Health System

saaronson@sheppardpratt.org

4109383125

Study Officials

• Scott T Aaronson, MD

  Sheppard Pratt Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research Programs

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 29, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 1, 2022
• Results First Posted: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)