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Trial registered on ANZCTR


Registration number
ACTRN12623001080617
Ethics application status
Approved
Date submitted
29/08/2023
Date registered
10/10/2023
Date last updated
13/04/2024
Date data sharing statement initially provided
10/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Label Safety and Efficacy Study of XW10508 Modified Release (MR) in Patients with Major Depressive Disorder
Scientific title
A Phase 2 Open Label Pilot Study of XW10508 Modified Release Tablets Assessing Safety and Efficacy in Patients with Major Depressive Disorder
Secondary ID [1] 310409 0
XW10508-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 331164 0
Condition category
Condition code
Mental Health 327936 327936 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cohort 1: 200 mg XW10508 MR oral tablets daily for 15 days; Cohort 2: 300 mg XW10508 MR oral tablets daily for 15 days; Cohort 3: 200 mg XW10508 MR oral tablets twice per week (Monday and Thursday) for 15 days; Cohort 4: 300 mg XW10508 MR oral tablets twice per week (Monday and Thursday) for 15 days. N=6 per cohort for a total of N=24. Participants are not allowed to participate in multiple cohorts. All cohorts will be started sequentially.
Intervention code [1] 326807 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335802 0
Change in Montgomery–Åsberg Depression Rating Scale (MADRS) score from baseline
Timepoint [1] 335802 0
Baseline and Day 16 post-intervention commencement
Secondary outcome [1] 425698 0
Assess patient's depression severity through change in Clinician Global Impression of Severity (CGI-S) from baseline
Timepoint [1] 425698 0
Baseline and Day 16 post-intervention commencement
Secondary outcome [2] 425699 0
Assess disease severity through Change in Patient Global Impression of Severity (PGI-S) from baseline
Timepoint [2] 425699 0
Baseline and Day 16 post-intervention commencement
Secondary outcome [3] 425700 0
Assess clinician's impression of disease improvement through Clinician Global Impression of Improvement (CGI-I) from baseline
Timepoint [3] 425700 0
Baseline and Day 16 post-intervention commencement
Secondary outcome [4] 425701 0
Assess patient's perception of improvement in depression through Patient Global Impression of Improvement (PGI-I)
Timepoint [4] 425701 0
Baseline and Day 16 post-intervention commencement
Secondary outcome [5] 426632 0
Frequency of self reported adverse events. Possible adverse events are nausea, dizziness, headache, somnolence.
Timepoint [5] 426632 0
For 16 days upon intervention commencement
Secondary outcome [6] 426633 0
Assess treatment-emergent dissociative symptoms through Clinician Administered Dissociative States Scale (CADSS)
Timepoint [6] 426633 0
For 16 days upon intervention commencement
Secondary outcome [7] 426634 0
Assess suicidal behavior through Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [7] 426634 0
For 16 days upon intervention commencement
Secondary outcome [8] 426635 0
Monitor vital signs (blood pressure and heart rate assessed using a blood pressure monitor, body temperature, respiratory rate assessed using a pulse oximeter).
Timepoint [8] 426635 0
For 16 days upon intervention commencement
Secondary outcome [9] 426636 0
Blood levels of esketamine.
Timepoint [9] 426636 0
Day 16 post-intervention commencement
Secondary outcome [10] 427238 0
Blood levels of noresketamine.
Timepoint [10] 427238 0
Day 16 post-intervention commencement

Eligibility
Key inclusion criteria
Diagnosis of Major Depressive Disorder without psychotic features diagnosed by two Structured Clinical Interview for Axis I Disorders (SCID-I) or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with symptoms present for at least 28 days.
MADRS total score of greater than or equal to 24 at screening.
Patients with an inadequate response to an adequate trial of 1, 2 or 3 antidepressants in the current Major Depressive Episode.
Current antidepressant treatment stable for at least 30 days prior to screening and will remain unchanged throughout the study.
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
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant medical conditions (e.g., history of bipolar disorder, schizophrenia, cognitive disorder, PTSD, panic disorder).
History of suicide attempt or risk of suicide associated with the current episode of MDD.
Psychiatric hospitalization during current Major Depressive Disorder episode.
Inadequate response to an adequate trial of 4 or more antidepressants in the current Major Depressive Episode.
History of substance abuse per DSM-5.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
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
Recruiting
Date of first participant enrolment
Anticipated
16/10/2023
Actual
4/12/2023
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
13/09/2024
Actual
Sample size
Target
24
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25408 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 41148 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 314619 0
Commercial sector/Industry
Name [1] 314619 0
XW Laboratories (Australia) Pty Ltd
Country [1] 314619 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
XW Laboratories (Australia) Pty Ltd
Address
58 Gipps Street Collingwood, VIC 3066
Country
Australia
Secondary sponsor category [1] 316581 0
None
Name [1] 316581 0
Address [1] 316581 0
Country [1] 316581 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313642 0
Central Adelaide Local Health Network (CALHN) HREC
Ethics committee address [1] 313642 0
Port RoadAdelaide SA 5000
Ethics committee country [1] 313642 0
Australia
Date submitted for ethics approval [1] 313642 0
31/07/2023
Approval date [1] 313642 0
06/09/2023
Ethics approval number [1] 313642 0

Summary
Brief summary
This is an open-label pilot study to assess XW10508 MR safety, tolerability and efficacy in patients with Major Depressive Disorder. The hypothesis is oral XW10508 MR 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 128846 0
Prof Guy Ludbrook, MBBS, FANZCA, PhD, GAICD
Address 128846 0
PARC Clinical Research - Royal Adelaide HospitalLevel 4C, Wayfinding 4C610, Port Road, Adelaide, SA 5000
Country 128846 0
Australia
Phone 128846 0
+61 0882222712
Fax 128846 0
Email 128846 0
guy.ludbrook@sa.gov.au
Contact person for public queries
Name 128847 0
Mrs Beth Zib
Address 128847 0
XWPharma, 303 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065
Country 128847 0
United States of America
Phone 128847 0
+1 650 996 7838
Fax 128847 0
Email 128847 0
beth.zib@xwpharma.com
Contact person for scientific queries
Name 128848 0
Mrs Beth Zib
Address 128848 0
XWPharma, 303 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065
Country 128848 0
United States of America
Phone 128848 0
+1 650 996 7838
Fax 128848 0
Email 128848 0
beth.zib@xwpharma.com

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


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.