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Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)

XanaCIDD: A Double-Blind, Randomized, Placebo Controlled, Parallel-Group Trial to Assess the Safety, Tolerability, and Efficacy of Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition

NCT05657691•Actinogen Medical

View on ClinicalTrials.gov

Summary

Xanamem is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD). This XanaCIDD Phase II study in MDD is to investigate the safety and efficacy of Xanamem™ in treating patients with cognitive and depressive symptoms. Trial participants will be randomized to either receive 10mg of Xanamem™ once daily or a Placebo at a 1:1 ratio in a double-blinded fashion.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
•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.

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.
+2 more criteria

Locations (12)

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, Australia

Genesis Research Services

Newcastle, New South Wales, Australia

Paratus Clinical Research Brisbane

Brisbane, Queensland, Australia

USC Clinical Trials

Sippy Downs, Queensland, Australia

Ramsay Clinic Albert Road

Melbourne, Victoria, Australia

Monash Alfred Psychiatry Research Centre

Melbourne, Victoria, Australia

NeuroCentrix

Noble Park, Victoria, Australia

St Pancras Clinical Research

London, United Kingdom

Clerkenwell Health

London, United Kingdom

MAC Clinical Research - Manchester

Manchester, United Kingdom

Key Dates

Start Date

November 28, 2022

Primary Completion Date

July 1, 2024

Completion Date

July 1, 2024

Last Updated

January 22, 2025

Enrollment

167

ACTUAL participants

Conditions

Major Depressive DisorderMDDCognitive Impairment

Interventions

Xanamem™

DRUG

Placebo

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Sense4Safety Intervention

Choline to Improve Malnutrition and Enhance Cognition

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk