Bipolar DepressioniTBS-BIPNCT02740244
Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression
A study testing active iTBS in people with Bipolar Depression, run by Hôpital le Vinatier.
Trial summary
The aim is to evaluate the evaluate the clinical interest and the safety of repetitive transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2015
- Phase
- Interventional
- 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
- Bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, DSM-IV criteria
- Montgomery and Asberg depression scale > 20
Who cannot join
- other psychiatric features, rapid cycles
- Benzodiazepines intake
- pregnancy
About this study
Official title: Effects of Intermittent Theta Burst Stimulation Applied Over the Left Dorsolateral Prefrontal Cortex in Patients With Treatment-resistant Bipolar Depression
The aim is to evaluate the evaluate the clinical interest and the safety of repetitive transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar disorder.
Read the detailed description
Methods: A double-blind randomized sham-controlled pilot study will be conducted in 40 patients with bipolar treatment-resistant depression receiving either active (n=20) or sham (n=20) iTBS over the left dorsolateral prefrontal cortex.
Depression severity will be assessed by an investigator blinded to iTBS condition before and after 10 to 30 iTBS sessions depending on remission onset. Remission will be defined as Beck Depression Inventory, BDI score<10.
Objective/Hypothesis: The investigators hypothesized the superiority of active iTBS over sham ITBS
- Conditions
- Bipolar Depression
- Being tested
- active iTBS, sham iTBS
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active iTBSDevice
Also called intermittent Theta Burst stimulation; rTMS stimulator, rTMS
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65)
sham iTBSDevice
Also called sham intermittent Theta Burst stimulation; sham rTMS
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a sham figure-eight coil (MCF-P-B65)
| Study group | Role | What they receive |
|---|---|---|
| active iTBS | Active comparator | Participants will receive 10 to 30 sessions of active intermittent theta burst stimulation (iTBS) consisting in delivering 2 s train of bursts containing three pulses at 50 Hz repeated each 200 ms every 10 s (iTBS). Each iTBS session contained 990 pulses and lasted 6 min. Stimulation intensity will be set at 80% of the patient's resting motor threshold. iTBS will be applied twice per day, with at least three hours between each session. Ten to 30 sessions will be delivered until patient achieved remission (i.e., 13-item Beck Depression Inventory (BDI13) score < 10). iTBS will be applied over the left dorsolateral prefrontal cortex (DLPFC) according to the individual's 3D-T1 MRI. Receives: Device: active iTBS |
| sham iTBS | Sham comparator | The same protocol (location, intensity, parameters of stimulation) will be applied using a commercial sham coil. Receives: Device: sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Self-reported clinical scale with 13 items
Measured: 2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJan 2011
- Primary completionFeb 2011
- Study completionJan 2015
Why it stopped: difficulties of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Szekely, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740244
- Sponsor's protocol ID
- 1018 rTMS DEP BIP
- Acronym
- iTBS-BIP
- Status last verified
- Jul 2018
- First submitted
- 6 Apr 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Theta Burst Stimulation Applied Over the Left Dorsolateral Prefrontal Cortex in Patients With Treatment-resistant Bipolar Depression
- ClinicalTrials.gov ID
- NCT02740244
- Acronym / sponsor ID
- iTBS-BIP / 1018 rTMS DEP BIP
- Conditions
- Bipolar Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties of recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Apr 2016 (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.
The aim is to evaluate the evaluate the clinical interest and the safety of repetitive transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar disorder.
Detailed description
Methods: A double-blind randomized sham-controlled pilot study will be conducted in 40 patients with bipolar treatment-resistant depression receiving either active (n=20) or sham (n=20) iTBS over the left dorsolateral prefrontal cortex.
Depression severity will be assessed by an investigator blinded to iTBS condition before and after 10 to 30 iTBS sessions depending on remission onset. Remission will be defined as Beck Depression Inventory, BDI score<10.
Objective/Hypothesis: The investigators hypothesized the superiority of active iTBS over sham ITBS
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active iTBS | Active comparator | Device: active iTBSParticipants will receive 10 to 30 sessions of active intermittent theta burst stimulation (iTBS) consisting in delivering 2 s train of bursts containing three pulses at 50 Hz repeated each 200 ms every 10 s (iTBS). Each iTBS session contained 990 pulses and lasted 6 min. Stimulation intensity will be set at 80% of the patient's resting motor threshold. iTBS will be applied twice per day, with at least three hours between each session. Ten to 30 sessions will be delivered until patient achieved remission (i.e., 13-item Beck Depression Inventory (BDI13) score < 10). iTBS will be applied over the left dorsolateral prefrontal cortex (DLPFC) according to the individual's 3D-T1 MRI. |
| sham iTBS | Sham comparator | Device: sham iTBSThe same protocol (location, intensity, parameters of stimulation) will be applied using a commercial sham coil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, DSM-IV criteria
- Montgomery and Asberg depression scale > 20
Key exclusion criteria (3 listed)
- other psychiatric features, rapid cycles
- Benzodiazepines intake
- pregnancy
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 |
|---|---|---|
| active iTBSAlso: intermittent Theta Burst stimulation; rTMS stimulator, rTMSTranscranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65) | Device | active iTBS |
| sham iTBSAlso: sham intermittent Theta Burst stimulation; sham rTMSTranscranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a sham figure-eight coil (MCF-P-B65) | Device | sham iTBS |
Primary outcome
Beck Depression Inventory
Time frame: 2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)
Self-reported clinical scale with 13 items
Results and safety
The study was stopped early (reason given: difficulties of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Bipolar Depression
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder
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.
David Szekely, MD principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
A study testing active iTBS in people with Bipolar Depression, run by Hôpital le Vinatier.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was stopped early (reason given: difficulties of recruitment). Results are not available in the source record.
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?
Beck Depression Inventory (time frame: 2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)). 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 2 Aug 2018.