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D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression (COGENT)
The goal of this clinical trial is to investigate if the drug D-Cycloserine (DCS) improves the antidepressant effects of Intermittent Theta Burst Stimulation (iTBS), a non-invasive brain stimulation therapy, in patients with Major Depressive Disorder (MDD). The main questions it aims to answer are: * Whether taking DCS prior to iTBS therapy will be more effective in improving depressive symptoms than iTBS therapy alone. * Compare the effect of DCS 100mg/day versus 50mg/day on depressive symptoms.
* Test the safety and tolerability of DCS. Participants will take either 50mg DCS per day, 100mg DCS or placebo prior to each iTBS treatment session. iTBS treatment will be administered daily, 5 days a week for 4 weeks.
Clinical measures will be conducted at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
Study details:
Major Depressive Disorder (MDD) is a common and debilitating condition with high rates of treatment resistance. Repetitive transcranial magnetic stimulation (rTMS) is an established treatment for treatment-resistant depression with few adverse effects. Intermittent Theta Burst Stimulation (iTBS) is a time-efficient form of rTMS with evidence base in the treatment of treatment-resistant depression (TRD).
The most commonly supported understanding of iTBS's mechanism of action appear to be its strengthening of connections between networks of neurons, which is modulated by the N-methyl-D-aspartate (NMDA) receptor. D-cycloserine (DCS) is a partial NMDA receptor agonist that has demonstrable impact on rTMS and TBS's neuromodulatory effects. This study protocol proposes the conduct of a prospective multi-site, parallel-arm design, randomized, double-blinded, placebo-controlled clinical trial to investigate DCS augmentation of iTBS in MDD.
We will investigate if adjuvant DCS 50mg or 100mg/day might have superior iTBS antidepressant augmentation effects.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-04-21
Primary completion: 2024-12-01
Study completion finish: 2024-12-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05591677
Intervention or treatment
DRUG: D-Cycloserine
DEVICE: Intermittent Theta Burst Stimulation
Conditions
- • Major Depressive Disorder
Find a site
Closest Location:
Monash Alfred Psychiatry Research Centre
Research sites nearby
Select from list below to view details:
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Active iTBS + active DCS 50mg/day
| DRUG: D-Cycloserine
|
ACTIVE_COMPARATOR: Active iTBS + active DCS 100mg/day
| DRUG: D-Cycloserine
|
PLACEBO_COMPARATOR: Active iTBS + placebo
| DEVICE: Intermittent Theta Burst Stimulation
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Rate of treatment response as per Montgomery Åsberg Depression Rating Scale (MADRS) | Clinical treatment response defined as \>/= 50% reduction in MADRS scores from baseline to primary study endpoint. Clinician-administered depression rating scale. The overall score ranges from 0 - 60. Cutoff points are 0-6 = normal, 7-9 = mild depression, 20-34 = moderate depression, \>34 = severe depression. | Determined at Week 4 (primary study endpoint) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change in Montgomery Åsberg Depression Rating Scale (MADRS) | Clinician-administered depression rating scale. The overall score ranges from 0 - 60. Cutoff points are 0-6 = normal, 7-9 = mild depression, 20-34 = moderate depression, \>34 = severe depression. | Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment. |
Change in Clinical Global Impression (CGI) | Clinician assessment of overall illness severity and global functioning. The CGI-Severity scale is clinician rated from 1-7 representing 'Not at all ill' to 'Severely ill'. The CGI-Improvement scale is also rated 1-7, representing the range between 'Very much improved' and 'Very much worse'. | Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment. |
Change in Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | Self-reported symptom rating scale for depression severity. Severity of depression can be judged based on the total score. 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression. | Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment. |
Beck's Anxiety Inventory (BAI) | Self-reported symptom rating scale for anxiety severity. The score range is 0-63. A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe. | Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment. |
International Trauma Questionnaire (ITQ) | Self-reported symptom rating of trauma-related symptoms and their severity. All ITQ items are answered on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). | Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment. |
Beck's Scale for Suicide Ideation (BSS) | Self-reported symptom rating scale for suicidal ideation. Scores range from 0 to 38, a higher score indicating a higher level of suicide ideation. | Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment. |
Change in World Health Organization Quality of Life (WHOQOL-BREF) | Self-reported rating scale of quality of life. Domains scores are calculated to range from 0-20 and scaled in a positive direction (ie. higher scores denote higher quality of life). | Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment. |
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