Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep
NCT ID: NCT04832750
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2021-05-03
2024-07-26
Brief Summary
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Detailed Description
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In this randomized, placebo-controlled study, 60 patients with treatment-resistant MDD (30 verum group, 30 sham group) and 60 patients with treatment-resistant MDD and comorbid BPD (30 verum group, 30 sham group) will receive two weeks of connectivity-informed iTBS of the left dorsolateral prefrontal cortex (DLPFC; 3 sessions per day, 5 days per week). Before and after the treatment phase, (functional) magnetic resonance imaging (fMRI) will be performed. The effects of iTBS will be tested in four domains: (1) symptom severity (MDD and BPD symptoms), (2) sleep quality (sleep questionnaires and various sleep parameters monitored via an electroencephalography (EEG) headband), (3) neurocognitive effects (vigilance and response inhibition measured with behavioral and fMRI tasks), and (4) interoception (interoceptive attention measured with behavioral and fMRI tasks). Furthermore, before the start of the two-weeks treatment, a single iTBS session ("forecaster session") will be conducted to explore the validity of early symptom/mood responses and hormonal changes for the prediction of the the treatment outcome. Treatment effects will be analyzed within and across patient groups (MDD and MDD + BPD). In addition, domain-specific treatment effects will be analyzed as a function of distinct iTBS targets within the DLPFC.To evaluate pathological biases, the investigators will compare the patients' data with a control group of 30 healthy participants who will also be tested twice (without iTBS).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Major Depressive Episode
At least one failed pharmaco trial in current episode
intermittent theta burst stimulation (iTBS) or sham stimulation
30 sessions of iTBS over 2 weeks (3 sessions per day, 5 days per week)
Major Depressive Episode with comorbid Borderline Personality Disorder
At least one failed pharmaco trial in current episode
intermittent theta burst stimulation (iTBS) or sham stimulation
30 sessions of iTBS over 2 weeks (3 sessions per day, 5 days per week)
Healthy Controls
No psychiatric disorders
No interventions assigned to this group
Interventions
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intermittent theta burst stimulation (iTBS) or sham stimulation
30 sessions of iTBS over 2 weeks (3 sessions per day, 5 days per week)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of major depressive disorder (MDD) according to DSM-V criteria.
* During the current episode, treatment-resistant MDD (at least one failed pharmacological trial of adequate dose and duration)
* For the MDD group with comorbid borderline personality disorder (BPD): diagnosis of BPD according to the Diagnotic Statistical Manual V (DSM-V) criteria.
* For healthy controls: no psychiatric or neurological illness.
Exclusion Criteria
* The participant does not fulfill requirements for iTBS treatment according to safety guidelines.
* The participant does not fulfill requirements for MRI measurements according to safety guidelines.
* Pregnancy or breast-feeding.
* Acute suicidality.
* Neurological illness (e.g. dementia, Parkinson's disease, chorea huntington, multiple sclerosis).
* increased current risk for epileptic seizure.
* comorbid diagnosis of schizophrenia or psychotic symptoms, bipolar disorder, and substance use disorder within the last 6 months.
* Conditions related to increased intracranial pressure.
* Brain injury or stroke.
18 Years
65 Years
ALL
Yes
Sponsors
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Marc Onken, M.Sc.
UNKNOWN
Christina Mueller, M.Sc.
UNKNOWN
University of Oldenburg
OTHER
Responsible Party
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Dirk Scheele
Deputy Lab Head
Principal Investigators
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René Hurlemann, Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, University of Oldenburg
Dirk Scheele, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, University of Oldenburg
Christina Mueller, M.Sc.
Role: STUDY_DIRECTOR
Department of Psychiatry, University of Oldenburg
Marc Onken, M.Sc.
Role: STUDY_DIRECTOR
Department of Psychiatry, University of Oldenburg
Locations
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Department of Psychiatry, University of Oldenburg
Bad Zwischenahn, , Germany
Countries
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References
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Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
Franzen PL, Buysse DJ. Sleep disturbances and depression: risk relationships for subsequent depression and therapeutic implications. Dialogues Clin Neurosci. 2008;10(4):473-81. doi: 10.31887/DCNS.2008.10.4/plfranzen.
Mutz J, Vipulananthan V, Carter B, Hurlemann R, Fu CHY, Young AH. Comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis. BMJ. 2019 Mar 27;364:l1079. doi: 10.1136/bmj.l1079.
Rock PL, Roiser JP, Riedel WJ, Blackwell AD. Cognitive impairment in depression: a systematic review and meta-analysis. Psychol Med. 2014 Jul;44(10):2029-40. doi: 10.1017/S0033291713002535. Epub 2013 Oct 29.
Tsuno N, Besset A, Ritchie K. Sleep and depression. J Clin Psychiatry. 2005 Oct;66(10):1254-69. doi: 10.4088/jcp.v66n1008.
Other Identifiers
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DREAMS
Identifier Type: -
Identifier Source: org_study_id