Stepped Care aiTBS 2 Depression Study (Ghent)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    68
  • sponsor
    University Ghent
Updated on 21 January 2021
depression
benzodiazepines
antidepressants
depressed mood
antipsychotics
selective serotonin reuptake inhibitors
depressed
major depressive disorder
sham treatment

Summary

Antidepressant-free unipolar melancholic depressed patients (at least stage 2 treatment-resistant) will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews. Because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. Only habitual benzodiazepine agents will be allowed.

STEP 1: Patients will be treated with in total 20 accelerated intermittent Theta Burst Stimulation (aiTBS) sessions (3000 pulses/session) over the left dorsolateral prefrontal cortex, which will be spread over 4 days. On each stimulation day, a given patient will receive 5 sessions with a between-session delay of 15 minutes. Patients will be randomized to receive either the real aiTBS or sham treatment (first week). However, the sham group will receive real aiTBS treatment with 10 days' time interval. The investigators expect that real aiTBS treatment and not sham will result in a significant and clinical meaningful response.

STEP 2: To optimize treatment and reduce relapse following the iTBS treatment, in a stepped care approach, all patients then continue with cognitive control training (CCT) ten days later. This CCT consists of 20 sessions, spread over 4 weeks. Patients will be randomized to receive either real CCT or a control training. During this follow-up treatment, all patients will be prescribed antidepressant medication (SSRI) again. As iTBS treatment effects are known to decline over time, the investigators expect that combining aiTBS with a follow-up CCT therapy will stabilize the clinical effects over time compared to receiving the iTBS treatment alone.

For baseline comparisons, patients will be closely matched for gender and age with never-depressed, medication-free healthy volunteers. No volunteer will undergo treatment.

Details
Condition mood disorder, Major depression, Endogenous depression, Treatment Resistant Depression, Mood Disorders (Pediatric), Affective Disorders, Mood Disorders, major depressive disorders
Treatment SSRI, aiTBS, CCT
Clinical Study IdentifierNCT03288675
SponsorUniversity Ghent
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Endogenous depression or Major depression?
Do you have any of these conditions: Major depression or Mood Disorders or Treatment Resistant Depression or Endogenous depression or Mood Disorders (Pediatric) or Affective Disorders or ...?
Antidepressant-free unipolar major depression with melancholic features
Not responding to at least two trials with an antidepressant
Aged between 18-65 years old

Exclusion Criteria

Depression with bipolar/psychotic features
Dysthymia
Severe personality disorders
Active substance abuse/dependence within a year prior to inclusion
Pregnancy or without effective anticonception for the duration of the trial
ECT non-responder
No response to more than 9 antidepressants
Any neurological condition
Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker)
Any implanted metal device in the head region
Current or past history of epilepsy
Neurosurgical interventions
Known allergic reaction to radiotracers or associated compounds
Healthy volunteers may be accepted as control subjects
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