Bipolar DisorderPhase 2rTMSNCT00447096
rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II
A Phase 2 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Bipolar Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- History of Vagus Nerve Stimulation
- Currently in another investigational study
- Prior electroconvulsive therapy failure
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
About this study
Official title: rTMS (Repetitive Transcranial Magnetic Stimulation) for Acute Treatment of Depressed Phase of Bipolar Disorder Type II
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.
Read the detailed description
This is a double-blind randomized controlled trial of rTMS for outpatients in the depressive phase of BD-II. Participants will be evaluated at UT Southwestern Medical Center at Dallas. Forty eligible subjects will be randomized to either active treatment (n=20) or sham (no stimulation, n=20). Each subject will receive treatment 5 days per week for a total of 6 weeks. At the end of the 6 weeks, those who remain depressed will have the option of receiving 6 additional weeks of open rTMS treatment. We require these participants to meet the same eligibility criteria in the open phase (i.e. MADRS ≥15, YMRS <12) as in the initial double blind phase. At the completion of treatment, a follow-up appointment will be scheduled with a study physician to ensure that the participant is properly transitioning to clinical care and is not having a significant change in clinical status. Those who do not already have a treating physician will be referred to a new provider.
- Conditions
- Bipolar Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Bipolar Type II, Depression, rTMS
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Repetitive transcranial magnetic stimulation (rTMS).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Treatment arm will receive treatment 5 days a week for 6 weeks. Repetitive transcranial magnetic stimulation (rTMS) treatment. Receives: 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
QIDS-C (Quick Inventory of Depressive Symptomatology-Clinical Rated)
Measured: 3 year
Secondary outcomes (6)
MADRS(Montgomery Asberg Depression Rating Scale)
Measured: 3 year
IDS-C (Inventory of Depressive Symptomatology- Clinician Rated)
Measured: 3 year
QIDS-SR (Quick Inventory of Depressive Symptomatology-Self Report)
Measured: 3 year
YMRS (Young Mania Rating Scale)
Measured: 3 year
Neuropsychological Testing
Measured: 3 year
rTMS safety/adverse events
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: No results, funding terminated and PI no longer at institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, Neuronetics
- Responsible party
- Sponsor
- Investigators
- F. Andrew Kozel, MD, MSCR, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447096
- Sponsor's protocol ID
- 102006-040
- Acronym
- rTMS
- Status last verified
- Jun 2016
- First submitted
- 12 Mar 2007
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS (Repetitive Transcranial Magnetic Stimulation) for Acute Treatment of Depressed Phase of Bipolar Disorder Type II
- ClinicalTrials.gov ID
- NCT00447096
- Acronym / sponsor ID
- rTMS / 102006-040
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Type II, Depression, rTMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No results, funding terminated and PI no longer at institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, Neuronetics
- Study start
- Feb 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 14 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a double-blind randomized controlled trial of rTMS for outpatients in the depressive phase of BD-II. Participants will be evaluated at UT Southwestern Medical Center at Dallas. Forty eligible subjects will be randomized to either active treatment (n=20) or sham (no stimulation, n=20). Each subject will receive treatment 5 days per week for a total of 6 weeks. At the end of the 6 weeks, those who remain depressed will have the option of receiving 6 additional weeks of open rTMS treatment. We require these participants to meet the same eligibility criteria in the open phase (i.e. MADRS ≥15, YMRS <12) as in the initial double blind phase. At the completion of treatment, a follow-up appointment will be scheduled with a study physician to ensure that the participant is properly transitioning to clinical care and is not having a significant change in clinical status. Those who do not already have a treating physician will be referred to a new provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Treatment arm will receive treatment 5 days a week for 6 weeks. Repetitive transcranial magnetic stimulation (rTMS) treatment. |
| Sham Arm | Sham comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Sham Arm will not receive any stimulation 5 days a week for 6 weeks. Sham transcranial magnetic stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Repetitive transcranial magnetic stimulation (rTMS). | Device | Sham Arm, Treatment Arm |
Primary outcome
QIDS-C (Quick Inventory of Depressive Symptomatology-Clinical Rated)
Time frame: 3 year
6 secondary outcomes
MADRS(Montgomery Asberg Depression Rating Scale)
Time frame: 3 year
IDS-C (Inventory of Depressive Symptomatology- Clinician Rated)
Time frame: 3 year
QIDS-SR (Quick Inventory of Depressive Symptomatology-Self Report)
Time frame: 3 year
YMRS (Young Mania Rating Scale)
Time frame: 3 year
Neuropsychological Testing
Time frame: 3 year
rTMS safety/adverse events
Time frame: 3 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F. Andrew Kozel, MD, MSCR principal investigator
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Bipolar Disorder, run by University of Texas Southwestern Medical Center at 1 site 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 8 inclusion and 18 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: withdrawn, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
QIDS-C (Quick Inventory of Depressive Symptomatology-Clinical Rated) (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2016.