NCT04832750|Completed
Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep
DREAMS
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DREAMS
Sponsor study identifier
observational
102
1 country
1
Study Start
May 3, 2021
Actual (reported)Primary Completion
June 14, 2024
Actual (reported)Study Completion
July 26, 2024
Actual (reported)Advances in repetitive transcranial magnetic stimulation (rTMS) protocols with intermittent theta-burst stimulation (iTBS) have significantly decreased the duration for one single session and thereby enabled accelerated treatment plans with multiple sessions per day, potentially reducing the total treatment duration. This randomized, placebo-controlled study investigates the effects of accelerated iTBS treatment with connectivity-informed neuronavigation on symptom severity, sleep, interoception, and cognitive control in patients with major depressive disorder and with or without comorbid borderline personality disorder using magnetic resonance imaging (MRI).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 26, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 26, 2021
Actual (reported)April 6, 2021
Actual (reported)May 3, 2021
Actual (reported)June 14, 2024
Actual (reported)July 26, 2024
Actual (reported)Change in depression severity after the treatment phase
Measured with the Montgomery Asberg Rating Scale (MARDS). Remission defined as MADRS score (range: 0 to 60) of less than or equal to 10. Response defined as a reduction of at least 50 percent from baseline in MADRS score.
Up to 5 weekdays after the last iTBS treatment session
Change in BPD severity after the treatment phase
Measured by the Zanarini rating scale for BPD (Zan-BPD, range 0-36). Remission is defined as score of 9 or less. Response defined as a decrease from baseline in Zan-BPD score of at least 20 percent of the scoring range, i.e. a reduction of 8 points or more.
Up to 5 weekdays after the last iTBS treatment session
Changes in neural responses in an interoception task before the first and after the last treatment session
At least one failed pharmaco trial in current episode
At least one failed pharmaco trial in current episode
No psychiatric disorders
30 sessions of iTBS over 2 weeks (3 sessions per day, 5 days per week)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients at the Department of Psychiatry, University of Oldenburg. The patients' diagnosis of MDD and BPD will be verified via the structured clinical interview for DSM-V. Healthy controls will be matched to the patient sample.
Department of Psychiatry, University of Oldenburg
Bad Zwischenahn, 26160, Germany
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.
Blood samples without DNA analysis Saliva samples without DNA analysis
René Hurlemann, Prof.
Department of Psychiatry, University of Oldenburg
Dirk Scheele, Dr.
Department of Psychiatry, University of Oldenburg
Christina Mueller, M.Sc.
Department of Psychiatry, University of Oldenburg
Marc Onken, M.Sc.
Department of Psychiatry, University of Oldenburg
102 participants (actual enrollment reported by the registry).
First Submitted
March 26, 2021
First Posted
April 6, 2021
Study Start
May 3, 2021
Actual (reported)Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
Measured with functional magnetic resonance imaging (fMRI) while performing an interoception task
Up to 5 weekdays before the first and after the last treatment session
Changes in neural responses in a cognitive control task before the first and after the last treatment session
Measured with functional magnetic resonance imaging (fMRI) while performing a cognitive control task
Up to 5 weekdays before the first and after the last treatment session
Changes in behavioral responses in an interoception task before the first and after the last treatment session
Measured as performance in an interoception task during fMRI
Up to 5 weekdays before the first and after the last treatment session
Changes in behavioral responses in a cognitive control task before the first and after the last treatment session
Measured as performance in a cognitive control task during fMRI
Up to 5 weekdays before the first and after the last treatment session
Changes in sleep staging over the treatment course
electroencephalography (EEG)-based sleep staging measured with a headband device with accelerometer and pulseoximeter
2 days of baseline measurement before the first iTBS session, daily over the treatment course for 10 days
Changes in brain connectivity measures
Up to 5 weekdays before the first and after the last treatment session
Changes in vigilance over the treatment course
Baseline immediately before the first iTBS session, daily over the treatment course for 10 days
Changes in symptom severity over treatment course
Baseline immediately before the first iTBS session, after 1 week of treatment, after 2 weeks of treatment, and at the follow-up 6 weeks after treatment
Changes in self-reported symptom severity over treatment course and at follow-up
Baseline immediately before the first iTBS session, daily over the treatment course for 10 days, 6 weeks after last iTBS session at the follow-up
Changes in Cortisol Awakening Response (CAR) from saliva concentrations
Up to 5 weekdays before the first and after the last treatment session
Contact the study team to confirm eligibility.
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.
Primary Completion
June 14, 2024
Actual (reported)Study Completion
July 26, 2024
Actual (reported)Last Updated
December 11, 2024
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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