Xanamem® in Adults With Major Depressive Disorder and Imp... | NCT05657691

Status Module

Name	Class
AXIOM Real Time Metrics	UNKNOWN

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
10 mg Xanamem™	Experimental	10 mg Xanamem™ capsule, to be administered orally once every morning with or without food	Drug: Xanamem™
Placebo	Placebo Comparator	Placebo capsule, to be administered orally once every morning with or without food	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xanamem™	Drug	Xanamem™ is formulated in green and cream-colored size 3, Coni-Snap-shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains the active pharmaceutical ingredient of UE2343.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of Xanamem on attention, including working memory	Change from Baseline to EOT in an Attention Composite of a Cognitive Test Battery (CTB) (Detection, Identification, and One Back tests)	6 Weeks (Baseline to Week 6 (end of treatment (EOT)))
Evaluation of the short-term safety and tolerability of Xanamem	Incidence and severity of treatment-emergent adverse events (TEAEs) Incidence of serious adverse events (SAEs) and SUSARs	6 Weeks (Baseline to Week 6 (EOT))

Secondary Outcomes

Measure	Description	Time Frame
Determine the effects of Xanamem on depressive symptoms	Change from Baseline to EOT on the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a 10-item diagnostic questionnaire used to assess the severity of depressive episodes and is designed to be sensitive to treatment effects. Each item is scored from 0 to 6, and overall scores range from 0 to 60. Higher scores indicate greater severity.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Male or female aged 18 to 75, inclusive.
Positive MDD primary diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).
Persistent depressive symptoms as determined by a Hamilton Depression Rating Scale (HAM-D) ≥ 17 at Screening.
Cognitive abilities on a coding test > 0.5 standard deviations below expected.
Self-reported subjective cognitive dysfunction.
Currently or previously treated with a stable dose of a first- or second-line antidepressant that is approved for the treatment of depression (but not a tricyclic antidepressant, monoamine oxidase inhibitor, or vortioxetine). If on current treatment, dose must be stable for at least 6 weeks.
Smokers are eligible if they are able to comfortably abstain from nicotine for 2 hours prior to scheduled cognitive assessments.
Able to comfortably abstain from caffeine intake for 4 hours prior to scheduled cognitive assessments.
Must provide written informed consent to participate in the trial and be willing and able to comply with the requirements of the protocol and complete all trial visits.

Key Exclusion Criteria:

Active suicidal ideation within the previous 3 months
On a tricyclic antidepressant, monoamine oxidase inhibitor, esketamine, or vortioxetine.
A history of clinically diagnosed dementia of any type
Previous clinically significant systemic illness or infection, including test positive COVID-19, within the past 4 weeks prior to Screening
Has a BMI or body weight that will interfere with participation in the trial
Type I or Type II diabetes requiring insulin
Clinically significant ECG abnormalities
Participation in another clinical trial of a drug or device
Trial participants who in the opinion of the Investigator exhibit physical, cognitive, or language impairments of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
Positive testing for HIV, hepatitis B surface antigen, or hepatitis C antibodies at Screening.
Participants with a history of drug abuse or addiction in the past 2 years
Current use of cannabis/marijuana, or tetrahydrocannabinol-containing medications.

Facility	Status	City	State	ZIP	Country	Contacts
Paratus Clinical Research Western Sydney		Blacktown	New South Wales		Australia
Genesis Research Services

ID	Term
D003865	Depressive Disorder, Major
D060825	Cognitive Dysfunction