None listed
Conditions
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.
Interventions
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).
Sponsors
XW Laboratories (Australia) Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed