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An Open Label Trial of TMS Therapy for Bipolar Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Sheppard Pratt Health System
Sponsor:
Collaborator:
Linden Oaks Medical Group at Edward-Elmhurst Healthcare in Naperville, Illinois.
Information provided by (Responsible Party):
Scott T. Aaronson, M.D, Sheppard Pratt Health System
ClinicalTrials.gov Identifier:
NCT02640950
First received: December 18, 2015
Last updated: December 22, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention
Bipolar Depression
Device: NeuroStar TMS

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Sheppard Pratt Health System:

Primary Outcome Measures:
  • The percentage of patients who respond or remit after 30 to 35 treatments based off of the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
    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. We will subdivide patients based on the diagnosis of either bipolar I or bipolar II to compare effectiveness between those groups.

  • The percentage of patients who meet criteria for onset of manic symptoms based on the Young Mania Rating Scale (YMRS). [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D) to calculate percentage of patients meeting response criteria [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]

    HAM-D response criteria will be based off a HAM-D score drop of at least 50%. Remission HAM-D score will be 7 or less. For the patients meeting remission criteria, we will calculate the number of treatments required to achieve remission. Patients who only meet response criteria will be treated for 30 to 35 sessions.

    Responders and remitters will also be followed for six months after the final treatment to see the durability of response. Percentage of patients' meeting relapse criteria will be calculated.


  • Clinical Global Impression (CGI) to calculate percentage of patients meeting response criteria [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]

    Remission criteria for the CGI score will be a 2 or less. For the patients meeting remission criteria, we will calculate the number of treatments required to achieve remission. Patients who only meet response criteria will be treated for 30 to 35 sessions.

    Responders and remitters will also be followed for six months after the final treatment to see the durability of response. Percentage of patients' meeting relapse criteria will be calculated.



Estimated Enrollment: 30
Study Start Date: December 2015
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-Label TMS
Active Transcranial Magnetic Stimulation
Device: NeuroStar TMS
Transcranial Magnetic Stimulation
Other Name: Transcranial Magnetic Stimulation

Detailed Description:

The investigators propose to screen patients with bipolar depression I or II, who are already on acceptable mood stabilization. They may or may not be on antidepressants at the time of screening but subjects on antidepressants would be taken off them before completing the screening phase. Those patients who have a depression of at least moderate severity without significant symptoms of activation or mania will be started on a course of open label TMS treatment of up to 35 sessions. Safety and efficacy assessments will be done weekly. Patients will complete a course of treatment when they meet remission criteria (MADRS score < 10) or at the end of 30 treatments, whichever comes first. Patient who are still judged to be improving between treatment 25 and treatment 30 will be eligible to complete up to five addition treatments as the discretion of each site's principal investigator. Patients who meet response criteria (MADRS score decreases by at least 50%) will complete the full course of 30 to 35 TMS sessions. Patients will be withdrawn for safety concerns, particularly the onset of activation suggestive of mania or a mixed state.

Patients who meet response or remission criteria will be followed monthly for up to six months to evaluate the durability of response. They will be on standard mood stabilizing medications and psychotherapy per their clinician's discretion.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria- Phase II:

  1. Must be at least 18 years old.
  2. 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.
  3. 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.
  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.
  5. 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.
  6. If female of childbearing potential, patients must

    1. have a negative urine pregnancy test at screening, and
    2. not be nursing or planning a pregnancy, and
    3. 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

Females of childbearing potential who are abstinent can enroll in the study.

Exclusion Criteria- Phase II:

  1. May not be directly affiliated with Sheppard Pratt Clinical Research Programs or be immediate family of Research Programs personnel.
  2. Must not have another primary Axis I diagnosis.
  3. The subject must not have stopped an antidepressant less than two weeks before starting TMS treatment or unable to discontinue antidepressant therapy.
  4. Should have no previous history of psychosis or substance dependence or abuse within the six months prior to Screening
  5. Presence of an Axis II disorder felt by the investigator to potentially interfere with study compliance would exclude a potential participant.
  6. Should not have prior intolerance of TMS or significant lack of response to adequate trials of TMS.
  7. Should not have a lifetime history of lack of response to ECT or VNS.
  8. Should not have any medical condition likely to interfere with safe study participation.
  9. 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.
  10. 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.
  11. Current suicide risk, as evidenced:

    1. It is the judgment of the investigator that the patient may be at risk for suicide
    2. The patient has rated a "yes" to question 4 or question 5 on the Screening C-SSRS
    3. The patient has attempted suicide within the past 12 months prior to Screening.
  12. History of head injury, epilepsy or seizure disorder, non-removable metallic implants or objects in or around the head.

Inclusion Criteria- Phase III Patients who meet MADRS criteria for response or remission will enter Phase III, the six month follow-up phase of the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02640950

Contacts
Contact: Whitney T Davis, MA 410-938-3135 wdavis@sheppardpratt.org
Contact: Jennifer H Sklar, MS 410-938-3136 jsklar@sheppardpratt.org

Locations
United States, Illinois
Linden Oaks Medical Group at Edward-Elmhurst Healthcare Not yet recruiting
Naperville, Illinois, United States, 60540
Contact: Philip Janicak, MD    312-942-5375      
United States, Maryland
Sheppard Pratt Health System Recruiting
Baltimore, Maryland, United States, 21204
Contact: Whitney T Davis, MA    410-938-3135    wdavis@sheppardpratt.org   
Contact: Jennifer H Sklar, MS    410-938-3136    jsklar@sheppardpratt.org   
Sponsors and Collaborators
Sheppard Pratt Health System
Linden Oaks Medical Group at Edward-Elmhurst Healthcare in Naperville, Illinois.
Investigators
Principal Investigator: Scott T Aaronson, MD Sheppard Pratt Health System
  More Information

Responsible Party: Scott T. Aaronson, M.D, Director, Clinical Research Programs, Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT02640950     History of Changes
Other Study ID Numbers: 794736-5 
Study First Received: December 18, 2015
Last Updated: December 22, 2015
Health Authority: United States: Sheppard Pratt Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders

ClinicalTrials.gov processed this record on July 25, 2016