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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
Scientific title
A Phase 2 Double-Blind Study of XW10508 Tablets Assessing Safety
and Efficacy in Patients with Major Depressive Disorder
Secondary ID [1] 313462 0
XW10508-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 335864 0
Condition category
Condition code
Mental Health 332449 332449 0 0
Depression

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 330035 0
Treatment: Drugs
Comparator / control treatment
Placebo-controlled.
The placebo tablets are composed of microcellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 339989 0
Change in Montgomery–Åsberg Depression Rating Scale (MADRS) score from baseline
Timepoint [1] 339989 0
Baseline and Day 28 post-intervention commencement
Secondary outcome [1] 442231 0
Assess patient's depression severity through change in Clinician Global Impression of Severity (CGI-S) from baseline
Timepoint [1] 442231 0
Baseline and Day 28 post-intervention commencement
Secondary outcome [2] 442232 0
Assess disease severity through Change in Patient Global Impression of Severity (PGI-S) from baseline
Timepoint [2] 442232 0
Baseline and Day 28 post-intervention commencement
Secondary outcome [3] 442233 0
Assess clinician's impression of disease improvement through Clinician Global Impression of Improvement(CGI-I) from baseline
Timepoint [3] 442233 0
Baseline and Day 28 post-intervention commencement
Secondary outcome [4] 442234 0
Assess patient's perception of improvement in depression through Patient Global Impression of Improvement (PGI-I)
Timepoint [4] 442234 0
Baseline and Day 28 post-intervention commencement
Secondary outcome [5] 442235 0
Frequency of self reported adverse events. Possible adverse events are nausea, dizziness, headache, somnolence.
Timepoint [5] 442235 0
For 28 days upon intervention commencement
Secondary outcome [6] 442236 0
Assess treatment-emergent dissociative symptoms through Clinician Administered Dissociative States Scale (CADSS)
Timepoint [6] 442236 0
For 28 days upon intervention commencement
Secondary outcome [7] 442237 0
Assess suicidal behavior through Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [7] 442237 0
For 28 days upon intervention commencement
Secondary outcome [8] 442238 0
Monitor vital signs (blood pressure and heart rate)
Timepoint [8] 442238 0
For 28 days upon intervention commencement
Secondary outcome [9] 442239 0
Blood levels of esketamine
Timepoint [9] 442239 0
Day 2 post-intervention commencement
Secondary outcome [10] 442240 0
Blood levels of noresketamine
Timepoint [10] 442240 0
Day 2 post-intervention commencement
Secondary outcome [11] 443623 0
Change in Hamilton Depression Rating Scale (HAM-D) score from baseline
Timepoint [11] 443623 0
Baseline and Day 28 post-intervention commencement

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

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
2/01/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317898 0
Commercial sector/Industry
Name [1] 317898 0
XW Laboratories (Australia) Pty Ltd
Country [1] 317898 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
XW Laboratories (Australia) Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320242 0
None
Name [1] 320242 0
Address [1] 320242 0
Country [1] 320242 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316587 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 316587 0
https://bellberry.com.au/
Ethics committee country [1] 316587 0
Australia
Date submitted for ethics approval [1] 316587 0
27/11/2024
Approval date [1] 316587 0
Ethics approval number [1] 316587 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138330 0
Prof Malcolm Hopwood, MBBS, MPM, MD, FRANZCP
Address 138330 0
Ramsay Clinic Albert Road, 31 Albert Road, Melbourne, VIC, 3004
Country 138330 0
Australia
Phone 138330 0
+61 0392793518
Fax 138330 0
Email 138330 0
[email protected]
Contact person for public queries
Name 138331 0
Raquel Moreira
Address 138331 0
XW Laboratories (Australia) Pty Ltd, Level 7 330 Collins Street Melbourne VIC 3000
Country 138331 0
Australia
Phone 138331 0
+358 452335304
Fax 138331 0
Email 138331 0
[email protected]
Contact person for scientific queries
Name 138332 0
Raquel Moreira
Address 138332 0
XW Laboratories (Australia) Pty Ltd, Level 7 330 Collins Street Melbourne VIC 3000
Country 138332 0
Australia
Phone 138332 0
+358 452335304
Fax 138332 0
Email 138332 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.