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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)
Scientific title
D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression: A Multi-Site, Randomised, Placebo-Controlled Trial (COGENT)
Secondary ID [1] 0 0
567-22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of treatment response as per Montgomery Åsberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
Determined at Week 4 (primary study endpoint)
Secondary outcome [1] 0 0
Change in Montgomery Åsberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
Secondary outcome [2] 0 0
Change in Clinical Global Impression (CGI)
Timepoint [2] 0 0
Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
Secondary outcome [3] 0 0
Change in Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Timepoint [3] 0 0
Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
Secondary outcome [4] 0 0
Beck's Anxiety Inventory (BAI)
Timepoint [4] 0 0
Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
Secondary outcome [5] 0 0
International Trauma Questionnaire (ITQ)
Timepoint [5] 0 0
Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
Secondary outcome [6] 0 0
Beck's Scale for Suicide Ideation (BSS)
Timepoint [6] 0 0
Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
Secondary outcome [7] 0 0
Change in World Health Organization Quality of Life (WHOQOL-BREF)
Timepoint [7] 0 0
Administered at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Blue Bell Health, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Gold Coast Hospital and Health Service
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leo Chen, MBBS PhD FRANZCP
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kaila Bianco
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 6564
Fax 0 0
Email 0 0
tms-trials@monash.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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