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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05591677
Registration number
NCT05591677
Ethics application status
Date submitted
16/10/2022
Date registered
24/10/2022
Titles & IDs
Public title
D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression (COGENT)
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Scientific title
D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression: A Multi-Site, Randomised, Placebo-Controlled Trial (COGENT)
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Secondary ID [1]
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567-22
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - D-Cycloserine
Treatment: Devices - Intermittent Theta Burst Stimulation
Active comparator: Active iTBS + active DCS 50mg/day - Active iTBS (600 pulses), 5 days/week x 4 weeks + active DCS 50mg/day x 2 weeks, taken 2-hours prior to scheduled iTBS treatment.
Active comparator: Active iTBS + active DCS 100mg/day - Active iTBS (600 pulses), 5 days/week x 4 weeks + active DCS 100mg/day x 2 weeks, taken 2-hours prior to scheduled iTBS treatment.
Placebo comparator: Active iTBS + placebo - Active iTBS (600 pulses), 5 days/week x 4 weeks + placebo x 2 weeks, taken 2-hours prior to scheduled iTBS treatment.
Treatment: Drugs: D-Cycloserine
D-cycloserine (DCS) is a partial NMDA receptor agonist that has demonstrable impact on rTMS and TBS's neuromodulatory effects. Participants will be asked to orally ingest one capsule 2-hours prior to their scheduled iTBS treatment time.
Treatment: Devices: Intermittent Theta Burst Stimulation
Intermittent Theta Burst Stimulation (iTBS) will be administered with a magnetic stimulator using a figure-of-8 coil or equivalent FDA-approved device. Initial treatment coil localisation and individual calibration of stimulation intensity will be conducted by TMS-trained investigators/staff using standard approaches.67,68 Stimulation intensity will be at 90% of the individual's calibrated resting motor threshold. iTBS treatment session delivers 600 pulses and is approximately 3½ minutes in duration. The total pulse number applied over a course of 20 treatments will be 12,000. This regimen is analogous with the iTBS protocol approved by the US FDA to treat TRD.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of treatment response as per Montgomery Åsberg Depression Rating Scale (MADRS)
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Assessment method [1]
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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.
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Timepoint [1]
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Determined at Week 4 (primary study endpoint)
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Secondary outcome [1]
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Change in Montgomery Åsberg Depression Rating Scale (MADRS)
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Assessment method [1]
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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.
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Timepoint [1]
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Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
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Secondary outcome [2]
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Change in Clinical Global Impression (CGI)
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Assessment method [2]
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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'.
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Timepoint [2]
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Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
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Secondary outcome [3]
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Change in Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
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Assessment method [3]
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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.
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Timepoint [3]
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Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
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Secondary outcome [4]
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Beck's Anxiety Inventory (BAI)
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Assessment method [4]
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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.
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Timepoint [4]
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Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
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Secondary outcome [5]
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International Trauma Questionnaire (ITQ)
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Assessment method [5]
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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).
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Timepoint [5]
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Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
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Secondary outcome [6]
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Beck's Scale for Suicide Ideation (BSS)
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Assessment method [6]
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Self-reported symptom rating scale for suicidal ideation. Scores range from 0 to 38, a higher score indicating a higher level of suicide ideation.
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Timepoint [6]
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Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
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Secondary outcome [7]
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Change in World Health Organization Quality of Life (WHOQOL-BREF)
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Assessment method [7]
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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).
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Timepoint [7]
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Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
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Eligibility
Key inclusion criteria
* Diagnosis of major depressive episode (MDE), in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder or bipolar affective disorder.
* 18 years or older in age.
* Treatment resistant depression at Stage II of the Thase and Rush classification.56
* Baseline Montgomery Åsberg Depression Rating Scale score of = 20 (moderate-to-severe depression severity).57,58
* No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
* Demonstrated capacity to give informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Inability to provide informed consent.
* Medically unstable patients at the discretion of the investigator.
* Concomitant neurological disorder or a history of a seizure disorder.
* Participants who are pregnant.
* Current substance use meeting DSM-5 criteria for substance use disorder.
* Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder or delusional disorder as assessed by the Mini-International Neuropsychiatric Interview (MINI) at the time of screening.
* Diagnosis of any other mental disorder that is the participant's primary diagnosis or main mental health syndrome of concern at the time of screening, which may significantly affect psychiatric status and assessed as likely to impact trial participation, in the clinical judgement of the investigator.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Alfred Psychiatry Research Centre - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Blue Bell Health, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Government body
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Name [2]
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Gold Coast Hospital and Health Service
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05591677
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Leo Chen, MBBS PhD FRANZCP
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kaila Bianco
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Address
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Country
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Phone
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+61 3 9076 6564
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05591677