Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep

NCT04832750 | Completed

• 1 other identifier: DREAMS
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Major Depressive Episode; Major Depressive Disorder; Borderline Personality Disorder

Keywords

rTMS; Theta Burst Stimulation; Neuronavigation; Major Depressive Episode; Borderline Personality Disorder; Sleep; Interoception; Cognitive Control; fMRI

Outcome Measures

Primary Outcomes (7)

• 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

  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

Secondary Outcomes (10)

• 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

Study Arms (3)

Major Depressive Episode

At least one failed pharmaco trial in current episode

Device: intermittent theta burst stimulation (iTBS) or sham stimulation

Major Depressive Episode with comorbid Borderline Personality Disorder

At least one failed pharmaco trial in current episode

Device: intermittent theta burst stimulation (iTBS) or sham stimulation

Healthy Controls

No psychiatric disorders

Interventions

intermittent theta burst stimulation (iTBS) or sham stimulation DEVICE

30 sessions of iTBS over 2 weeks (3 sessions per day, 5 days per week)

Major Depressive Episode; Major Depressive Episode with comorbid Borderline Personality Disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Participant is able to provide consent.
• 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.

You may not qualify if:

• For the MDD group without BPD: BPD diagnosis
• 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.

Sponsors & Collaborators

• University of Oldenburg: lead
• Marc Onken, M.Sc.: collaborator
• Christina Mueller, M.Sc.: collaborator

Study Sites (1)

Department of Psychiatry, University of Oldenburg

Bad Zwischenahn, 26160, Germany

Location

Related Publications (5)

• 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.

  PMID: 29726344 BACKGROUND

• 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.

  PMID: 19170404 BACKGROUND

• 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.

  PMID: 30917990 BACKGROUND

• 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.

  PMID: 24168753 BACKGROUND

• Tsuno N, Besset A, Ritchie K. Sleep and depression. J Clin Psychiatry. 2005 Oct;66(10):1254-69. doi: 10.4088/jcp.v66n1008.

  PMID: 16259539 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples without DNA analysis Saliva samples without DNA analysis

MeSH Terms

Conditions

Depressive Disorder, Major; Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Personality Disorders

Study Officials

• René Hurlemann, Prof.

  Department of Psychiatry, University of Oldenburg

  PRINCIPAL INVESTIGATOR

• Dirk Scheele, Dr.

  Department of Psychiatry, University of Oldenburg

  PRINCIPAL INVESTIGATOR

• Christina Mueller, M.Sc.

  Department of Psychiatry, University of Oldenburg

  STUDY DIRECTOR

• Marc Onken, M.Sc.

  Department of Psychiatry, University of Oldenburg

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Lab Head

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 6, 2021
• Study Start: May 3, 2021
• Primary Completion: June 14, 2024
• Study Completion: July 26, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

DE (1)