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Bipolar DisorderNCT03603561

Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression

A study testing cTBS in people with Bipolar Disorder and Bipolar Depression, run by Universiteit Antwerpen at 2 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
cTBS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesBelgium
Study dates
1 Aug 2018to Jul 2020
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnostic and Statistical Manual-IV defined bipolar subjects (bipolar types I and II), depressed or mixed phase, confirmed by the Mini-International Neuropsychiatric Interview (MINI-plus 5.0.0.)
  • Hamilton Rating Scale for Depression-17 score of 17 or more.
  • Stable psychotropic medication regimen for at least 2 weeks prior to randomization and patient is willing to remain on a stable regimen from screening (S) after the second measurement point T2 (2 to 3 weeks).
  • Antidepressants:
  • On stable antidepressant treatment for 4 weeks.
  • Stable antidepressant medication but dose has been recently changed (higher/lower dose): duration of 2 weeks should lie between change of medication dose and screening (S).
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  • If the patient recently stopped the antidepressant treatment, a wash-out period of 14 days is necessary.
  • Mood stabilizers:
  • On a stable dose of mood-stabilizing medication (e.g., lithium, valproate, carbamazepine, lamotrigine, antipsychotic agents) for at least 4 weeks. In case of change in dose of the mood stabilizing medication, participants can be included given that no or minimal improvement is seen after 2 weeks of dosing.
  • Atypical antipsychotics
  • On a stable dose of for at least 4 weeks. In case of change in dose of antipsychotics, participants can be included given that no or minimal improvement is seen after 2 weeks of dosing.
  • Benzodiazepines are permitted to a maximum allowed dose of equivalent of 40 mg diazepam. If the dosage has been recently changed: stable dose during 2 weeks.
  • Able to read, understand and sign the Informed Consent Form.

Who cannot join

  • Contra-indications for TMS treatment:
  • Current or past history of epilepsy.
  • The risk of seizure with any reasons.
  • Organic brain damage (for example mass brain lesions, cerebrovascular accident, …).
  • Neurosurgical interventions.
  • Having a pacemaker or metal or magnetic objects in the brain.
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  • Unipolar depression
  • Psychotic disorder (MINI-plus 5.0.0; DSM-IV codes 295.10, 295.20, .30, .40, .60, .70, .90, 297.10, 298.90); exceptions are: depression with psychotic features MINI-Plus 5.0.0; DSM code 296.23)
  • Current alcohol dependence (MINI-plus 5.0.0. DSM IV code 303.9) (in the last year)
  • Current substance abuse or dependence (DSM-IV codes 304.00-.90, 305.20 -.70) (in the last year), with the exception of nicotine and caffeine (DSM IV codes 305.10 and 305.90)
  • Suicide attempt within 6 months before the start of the study
  • Pregnancy or lactation

Trial locations and contacts

2 sites in 1 country.

Kaat Hebbrecht, Dr contact

15304048 ext. +32

kaat.hebbrecht@emmaus.be

Bernard Sabbe, PhD contact

15304034 ext. +32

bernard.sabbe@ua.ac.be

Belgium2 sites, 2 recruiting

  • University Hospital of Brussels

    Brussels, 1000

    Chris Baeken, PhD, 9 332 43 94 ext. +32, chris.baeken@uzbrussel.be

    Dieter Zeeuws, MD, 2 477 60 12 ext. +32, dieter.zeeuws@uzbrussel.be

    Not yet recruiting

  • University Psychiatric Hospital Duffel

    Duffel, 2570

    Kaat Hebbrecht, Dr, 15304048 ext. +32, kaat.hebbrecht@emmaus.be

    Bernard Sabbe, PhD, 15304034 ext. +32, bernard.sabbe@ua.ac.be

    Recruiting

Other trials in Belgium

About this study

Official title: Continuous Theta Burst Transcranial Magnetic Stimulation as an add-on Treatment for Bipolar Depression: a Multicenter Randomized Sham-controlled Trial

This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases.

Phase 1: Bipolar depressed patients will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews (M.I.N.I.-Plus 5.0.0, HRSD-17). The presence of exclusion criteria will be evaluated. Eligible patients will undergo MRI brain imaging for TMS neuronavigation

Read more

Phase 2: Baseline clinical, cognitive and psychomotor assessments will take place. Patients will also undergo blood samples for laboratory and research assessments.

TBS involves applying triple-pulse 50 Hz bursts given at a rate of 5 Hz uninterrupted trains (1). Patients will be treated with in total 20 continuous Theta Burst Stimulation (cTBS) session (900 pulses per session) over the right dorsolateral prefrontal cortex, which will be spread over 4 days. A stimulation intensity of 100% of the subject's resting motor threshold (rMT) of the right abductor pollicis brevis muscle will used.

Patients will be randomized to receive either the real cTBS or sham treatment. Sham stimulation will be applied with a sham coil. The sham coil produces identical sounds but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. The investigators expect that real cTBS treatment and not sham will result in a significant and clinical meaningful response.

Phase 3: Two post-treatment assessment moments will take place respectively 3 (max. 4) days and 10 (max. 11) days after the last treatment day. The assessments are the same clinical, cognitive and psychomotor assessments as in phase 2.

Being tested
cTBS, Sham cTBS
Keywords
bipolar depression, TMS, transcranial magnetic stimulation, add-on treatment
Medical subject headings
Bipolar Disorder, Depression, Mood Disorders, Mental Disorders

What participants receive

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

  • cTBSDevice

    In the cTBS arm, the patients will receive 5 daily session cTBS (5 times uninterrupted train of 900 pulses) separated by a 15 min interval. Patients will be treated with in total 20 cTBS sessions over the right dorsolateral prefrontal cortex, spread over 4 days. A stimulation intensity of 100 % of the resting motor threshold (rMT) of the right abductor pollicis brevis muscle will be used.

  • Sham cTBSDevice

    The sham coil has been specifically developed to mimic the real one but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS.

Study groups in NCT03603561
Study groupRoleWhat they receive
Active cTBSActive comparatorNot described
Receives: Device: cTBS
Sham cTBSSham comparatorNot described
Receives: Device: Sham cTBS

What is being measured

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

  1. Changes in depression severity clinician-rated

    Hamilton rating scale for depression (HRSD-17); total scores ranging from 0 to 52. A higher score is indicative of greater depressive pathology

    Measured: Screening, baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

Secondary outcomes (14)

  1. Changes in depression severity self-report

    Beck Depression Inventory (BDI-II); total scores ranging from 0 to 63. Higher total scores indicate more severe depressive symptoms.

    Measured: Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

  2. Changes in suicidal thoughts - clinician-rated

    Columbia-suicide severity rating scale (total score ranges from 0 to 25; a higher score represent a higher intensity of suicidality)

    Measured: Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

  3. Changes in cognitive symptoms (1)

    Continuous performance test (CPT), a measure of a person's sustained and selective attention: d-prime (the quotient of hits/false alarms that indicate the response sensitivity for discrimination of target from nontarget stimuli). Greater scores represent better ability to distinguish and detect X and non-X stimuli (better sustained attention)

    Measured: Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

  4. Changes in cognitive symptoms (2)

    Symbol Digit Substitution Test (SDST), examining processing speed. Differentiating between the cognitive and the psychomotor processes of slowing (matching time and writing time; msec)

    Measured: Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

  5. Changes in cognitive symptoms (3)

    Stroop test; examining response inhibition (Stroop response interference score)

    Measured: Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

  6. Changes in psychomotor symptoms (1)

    CORE assessment of psychomotor functioning; total score ranging from 0 to 54. A higher score is indicative of psychomotor impairment (a score of 21 or more is indicative of melancholic depression)

    Measured: Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

  7. Changes in psychomotor symptoms (2)

    Accelometer tool (MotionWatch 8®, CamNtech, Cambridge, UK; measuring gross motor performance): total day activity level (counts per hour). Lower values indicate reduction in gross motor activity. *Cut-off levels from a control group are being collected in another research project of this research group.

    Measured: Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

  8. Changes in psychomotor symptoms (3)

    Line-copying task (LCT): initiation and movement time (msec)

    Measured: Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

  9. Change in biological markers (1)

    Plasma levels of C reactive protein (CRP)

    Measured: Baseline and 10 days after cTBS or sham (+/- day 14)

  10. Change in biological markers (2)

    Cytokines (pg/ml)

    Measured: Baseline and 10 days after cTBS or sham (+/- day 14)

  11. Change in biological markers (3)

    Kynurenines tryptophan catabolites (TRYCAT) levels (mmol/l)

    Measured: Baseline and 10 days after cTBS or sham (+/- day 14)

  12. Change in biological markers (4)

    Brain-derived neurotrophic factor (BDNF; ng/ml)

    Measured: Baseline and 10 days after cTBS or sham (+/- day 14)

  13. Differences in adverse events following cTBS or sham - self report

    Adverse effects questionnaire

    Measured: 3 days after cTBS or sham (+/- day 7)

  14. Differences in development of (hypo)manic symptoms

    Young mania rating scale (YMRS): evaluates the presence and severity of mania. The score ranges from 0 to 60. Scores higher than 12 are indicative for mania, scores of 2 or lower indicate euthymia.

    Measured: Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)

Timeline

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

  1. First posted27 Jul 2018
  2. Study start1 Aug 2018
  3. Primary completionJul 2020 (estimated)
  4. Study completionJul 2020 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603561
Sponsor's protocol ID
1808
Status last verified
Apr 2019
First submitted
5 Jun 2018
Last updated
25 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

    PubMed 15664172

Questions about this trial

What is this clinical trial studying?

A study testing cTBS in people with Bipolar Disorder and Bipolar Depression, run by Universiteit Antwerpen at 2 sites in Belgium.

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 13 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Apr 2019. 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 Belgium. 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Kaat Hebbrecht, Dr (15304048 ext. +32, kaat.hebbrecht@emmaus.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in depression severity clinician-rated (time frame: Screening, baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14)). 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 NCT03603561, 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 25 Apr 2019.

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