An Open Label Safety and Efficacy Study of XW10508 Modified Release (MR) in Patients with Major Depressive Disorder

A Phase 2 Open Label Pilot Study of XW10508 Modified Release Tablets Assessing Safety and Efficacy in Patients with Major Depressive Disorder

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623001080617

Enrollment

Registered

2023-10-10

Start date

2023-12-04

Completion date

2024-08-30

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

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.

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.

Outcome results