AIDA-DEP - Accelerated Intermittent theta-burst stimulation with D-cycloserine Augmentation for DEPression - a multicenter, randomized, placebo-controlled, double-blind clinical trial

Conditions

Major Depression, Major Depression Disorder (MDD)

Brief summary

Between-group difference in change of blinded rater MADRS total score from baseline to Day 28 (21-35) after first treatment day (interview by blinded external rater via video consultation documented on item level in eCRF).

Detailed description

Change in observer rated depressive symptoms (MADRS) to treatment day 12 and 180 and Clinical Global Impression (CGI) at day 12, 28, and 180, Response and remission rates at all time points on observer (MADRS) and self-rated depressive symptoms Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Survival time to initiation of new antidepressant treatment, hospitalization or death during the whole study period (until day 180), Change in score from baseline to Day 5, 12, 42, and 180 (end of study) self-rated depressive symptoms (QIDS-SR); Intensity in Suicidal Ideation from Columbia Suicide Severity Rating Scale (ISI-CSSR); anxiety symptoms, General Anxiety Disorder 7 (GAD-7); functioning, Sheehan Disability Scale (SDS); general health perception, EQ-5D-5L, Change in cognitive functioning (THINC-it); pre-attentive stimuli detection, Mismatch Negativity (MMN); frontal oxygenation (fNIRS); resting EEG measures including frequency spectra, microstates, and aperiodic activity.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGThe placebo product is a size 1

DRUGopaque

DRUGorange hard gelatine capsule

DRUGidentical in appearance and similar weight to the IMP. The placebo capsules will be filled with microcrystalline cellulose.

DRUGD-Cycloserine 100 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Between-group difference in change of blinded rater MADRS total score from baseline to Day 28 (21-35) after first treatment day (interview by blinded external rater via video consultation documented on item level in eCRF).	—

Secondary

Measure	Time frame
Change in observer rated depressive symptoms (MADRS) to treatment day 12 and 180 and Clinical Global Impression (CGI) at day 12, 28, and 180, Response and remission rates at all time points on observer (MADRS) and self-rated depressive symptoms Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Survival time to initiation of new antidepressant treatment, hospitalization or death during the whole study period (until day 180), Change in score from baseline to Day 5, 12, 42, and 180 (end of study) self-rated depressive symptoms (QIDS-SR); Intensity in Suicidal Ideation from Columbia Suicide Severity Rating Scale (ISI-CSSR); anxiety symptoms, General Anxiety Disorder 7 (GAD-7); functioning, Sheehan Disability Scale (SDS); general health perception, EQ-5D-5L, Change in cognitive functioning (THINC-it); pre-attentive stimuli detection, Mismatch Negativity (MMN); frontal oxygenation (fNIRS); resting EEG measures including frequency spectra, microstates, and aperiodic activity	—

Measure

Time frame

Change in observer rated depressive symptoms (MADRS) to treatment day 12 and 180 and Clinical Global Impression (CGI) at day 12, 28, and 180, Response and remission rates at all time points on observer (MADRS) and self-rated depressive symptoms Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Survival time to initiation of new antidepressant treatment, hospitalization or death during the whole study period (until day 180), Change in score from baseline to Day 5, 12, 42, and 180 (end of study) self-rated depressive symptoms (QIDS-SR); Intensity in Suicidal Ideation from Columbia Suicide Severity Rating Scale (ISI-CSSR); anxiety symptoms, General Anxiety Disorder 7 (GAD-7); functioning, Sheehan Disability Scale (SDS); general health perception, EQ-5D-5L, Change in cognitive functioning (THINC-it); pre-attentive stimuli detection, Mismatch Negativity (MMN); frontal oxygenation (fNIRS); resting EEG measures including frequency spectra, microstates, and aperiodic activity

—

Countries

Sweden

Outcome results

None listed