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Trial registered on ANZCTR
Registration number
ACTRN12625000128493p
Ethics application status
Submitted, not yet approved
Date submitted
10/01/2025
Date registered
5/02/2025
Date last updated
5/02/2025
Date data sharing statement initially provided
5/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
A Safety and Efficacy Study of XW10508 in Patients with Major Depressive Disorder
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Scientific title
A Phase 2 Double-Blind Study of XW10508 Tablets Assessing Safety
and Efficacy in Patients with Major Depressive Disorder
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Secondary ID [1]
313462
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XW10508-104
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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
332449
332449
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
200 mg XW10508 or placebo oral tablets once per week for 4 weeks (N=24).
Treatment adherence will be monitored through drug accountability (drug tablet count on a weekly basis) and laboratory tests (level of XW10508 measured in the blood on a weekly basis).
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Intervention code [1]
330035
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Treatment: Drugs
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Comparator / control treatment
Placebo-controlled.
The placebo tablets are composed of microcellulose.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Change in Montgomery–Åsberg Depression Rating Scale (MADRS) score from baseline
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Assessment method [1]
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Montgomery–Åsberg Depression Rating Scale (validated questionnaire)
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Timepoint [1]
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Baseline and Day 28 post-intervention commencement
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Secondary outcome [1]
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Blood levels of noresketamine
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Assessment method [1]
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Measured in blood samples
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Timepoint [1]
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Day 2 post-intervention commencement
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Secondary outcome [2]
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Assess clinician's impression of disease improvement through Clinician Global Impression of Improvement(CGI-I) from baseline
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Assessment method [2]
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Clinician Global Impression of Improvement (validated questionnaire)
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Timepoint [2]
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Baseline and Day 28 post-intervention commencement
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Secondary outcome [3]
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Assess patient's depression severity through change in Clinician Global Impression of Severity (CGI-S) from baseline
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Assessment method [3]
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Clinician Global Impression of Severity (validated questionnaire)
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Timepoint [3]
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Baseline and Day 28 post-intervention commencement
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Secondary outcome [4]
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Blood levels of esketamine
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Assessment method [4]
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Measured in blood samples
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Timepoint [4]
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Day 2 post-intervention commencement
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Secondary outcome [5]
442234
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Assess patient's perception of improvement in depression through Patient Global Impression of Improvement (PGI-I)
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Assessment method [5]
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Patient Global Impression of Improvement (questionnaire designed for the study)
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Timepoint [5]
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Baseline and Day 28 post-intervention commencement
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Secondary outcome [6]
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Assess disease severity through Change in Patient Global Impression of Severity (PGI-S) from baseline
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Assessment method [6]
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Patient Global Impression of Severity (questionnaire designed for the study)
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Timepoint [6]
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Baseline and Day 28 post-intervention commencement
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Secondary outcome [7]
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Assess treatment-emergent dissociative symptoms through Clinician Administered Dissociative States Scale (CADSS)
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Assessment method [7]
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Clinician Administered Dissociative States Scale (validated scale)
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Timepoint [7]
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For 28 days upon intervention commencement
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Secondary outcome [8]
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Frequency of self reported adverse events. Possible adverse events are nausea, dizziness, headache, somnolence.
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Assessment method [8]
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Self reported adverse events
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Timepoint [8]
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For 28 days upon intervention commencement
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Secondary outcome [9]
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Assess suicidal behavior through Columbia-Suicide Severity Rating Scale (C-SSRS)
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Assessment method [9]
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Columbia-Suicide Severity Rating Scale (validated scale)
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Timepoint [9]
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For 28 days upon intervention commencement
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Secondary outcome [10]
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Change in Hamilton Depression Rating Scale (HAM-D) score from baseline
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Assessment method [10]
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Hamilton Depression Rating Scale (validated scale)
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Timepoint [10]
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Baseline and Day 28 post-intervention commencement
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Secondary outcome [11]
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Monitor vital signs (blood pressure and heart rate)
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Assessment method [11]
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Vital signs assessed using a blood pressure monitor, body temperature, respiratory rate assessed using a pulse oximeter
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Timepoint [11]
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For 28 days upon intervention commencement
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Eligibility
Key inclusion criteria
Diagnosis of Major Depression Disorder (MDD) must meet the DSM-5 diagnostic criteria for single-episode MDD (if single episode MDD, the duration must be greater than or equal to 2 years) or recurrent MDD, without psychotic features based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI).
MADRS total score of greater than or equal to 24 at screening.
Patients with an inadequate response to an adequate trial of 2 or 3 antidepressants in the current Major Depressive Episode.
Pass Massachusetts General Hospital Clinical Trial Network and Institute (MGH CTNI) SAFER interview
Current antidepressant treatment will remain stable (same dose and drug) for =30 days prior to screening and will remain unchanged throughout the study (e.g., no new antidepressant drugs or dose changes).
Female participants of childbearing potential must test negative in a serum pregnancy test at Screening and have a negative urine pregnancy test at the Baseline Visit. Women with childbearing potential must use an acceptable method of contraception during the study and for at least 30 days after completion of dosing.
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Minimum age
18
Years
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Maximum age
55
Years
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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
History of suicide attempt or risk of suicide associated with the current episode of MDD.
Current or prior (within 12 months) diagnosis of a psychiatric disorder or MDD with psychotic features, bipolar or related disorders, obsessive compulsive disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder, PTSD, or anorexia nervosa.
Active alcohol or drug use disorder (except nicotine), active within the past 12 months.
Psychiatric hospitalization during current Major Depressive Disorder episode.
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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)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/03/2025
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Actual
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Date of last participant enrolment
Anticipated
1/12/2025
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Actual
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Date of last data collection
Anticipated
2/01/2026
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Actual
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Sample size
Target
24
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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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Funding & Sponsors
Funding source category [1]
317898
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Commercial sector/Industry
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Name [1]
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XW Laboratories (Australia) Pty Ltd
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
XW Laboratories (Australia) Pty Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320242
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Country [1]
320242
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316587
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Bellberry Human Research Ethics Committee A
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Ethics committee address [1]
316587
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https://bellberry.com.au/
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Ethics committee country [1]
316587
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Australia
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Date submitted for ethics approval [1]
316587
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27/11/2024
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Approval date [1]
316587
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Ethics approval number [1]
316587
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Summary
Brief summary
This is a double-blind, randomized, placebo-controlled study to assess XW10508 safety, tolerability and efficacy in patients with Major Depressive Disorder. Patients will be randomized to receive 200 mg once per week for 4 weeks. The hypothesis is that oral XW10508 tablets will rapidly improve and maintain the treatment of depression symptoms without significant adverse effects and with good patient tolerability.
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Trial website
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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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Prof Malcolm Hopwood, MBBS, MPM, MD, FRANZCP
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Address
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Ramsay Clinic Albert Road, 31 Albert Road, Melbourne, VIC, 3004
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Country
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Australia
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Phone
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+61 0392793518
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Fax
138330
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Email
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[email protected]
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Contact person for public queries
Name
138331
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Raquel Moreira
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Address
138331
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XW Laboratories (Australia) Pty Ltd, Level 7 330 Collins Street Melbourne VIC 3000
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Country
138331
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Australia
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Phone
138331
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+358 452335304
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Fax
138331
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Email
138331
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[email protected]
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Contact person for scientific queries
Name
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Raquel Moreira
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Address
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XW Laboratories (Australia) Pty Ltd, Level 7 330 Collins Street Melbourne VIC 3000
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Country
138332
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Australia
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Phone
138332
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+358 452335304
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Fax
138332
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Email
138332
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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