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Bipolar DepressionNCT02640950

An Open Label Trial of TMS Therapy for Bipolar Depression

A study testing NeuroStar TMS in people with Bipolar Depression, run by Sheppard Pratt Health System at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Depression
What is being tested?
NeuroStar TMS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesUnited States
Study dates
Dec 2015to Jul 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
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  • 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.
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21204

  • Department of Psychiatry and Psychology, Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Read the 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.

Being tested
NeuroStar TMS
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeuroStar TMSDevice

    Also called Transcranial Magnetic Stimulation

    Transcranial Magnetic Stimulation

Study groups in NCT02640950
Study groupRoleWhat they receive
Open-Label TMSExperimentalActive Transcranial Magnetic Stimulation
Receives: Device: NeuroStar TMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 7 weeks

  2. 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.

    Measured: Up to 7 weeks

Secondary outcomes (4)

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

    The Hamilton Depression (HAM-D) Rating Scale is a scale used to measure one's depression. The scoring from the scale ranges 0 to 53. Higher scores indicate that a person is more depressed. The scoring ranges from 0-7 is normal, 8-13 is mild depression, 14-18 is moderate depression, 19-22 severe depression, and greater than or equal to 23 is very severe depression. The 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.

    Measured: Up to 7 weeks

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

    The Clinical Global Impression (CGI) Scale is used to determine the severity of a patient's depression. The scoring for the scale ranges from 1 to 7, where 1 indicates that the patient is normal and 7 indicates a severe depression.

    Remission criteria for the CGI score will be a 2 or less.

    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.

    Measured: Up to 7 weeks and 6 Month Follow Up

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

    For the patients meeting remission criteria (Total Number = 21) , 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.

    Measured: 7 Weeks

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

    For the patients meeting remission criteria (Total Number = 27) , 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.

    Measured: 7 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionJul 2020
  4. Study completionJul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02640950
Sponsor's protocol ID
794736-5
Status last verified
May 2022
First submitted
18 Dec 2015
Last updated
1 Jun 2022
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38780536

Questions about this trial

What is this clinical trial studying?

A study testing NeuroStar TMS in people with Bipolar Depression, run by Sheppard Pratt Health System at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02640950, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

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