A multicentre, double-blind, randomised,... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

18 - 35

Psychosis History

Excluded

Inclusion Criteria

Able to comprehend and willing to sign informed consent and comply with trial procedures.
Age ≥18 and ≤65 years.
BMI ≥18 and ≤35 kg/m2.
Primary diagnosis of major depressive disorder (DSM-5) with current episode ≤24 months confirmed by MINI 7.0.2.
Treatment-resistant depression (less than 50% improvement on ≥2 different optimised antidepressant treatments each ≥6 weeks) confirmed by TRD-C.
Stable antidepressant treatment for ≥6 weeks prior to baseline until follow-up.
HAM-D17 score ≥19 at screening and Visit 2a.
For females of childbearing potential: willingness to use highly effective contraception from consent until 28 days after last IP.
For male subjects with partner of childbearing potential: use adequate contraception or sexual abstinence from consent until 28 days after last IP.
Outpatient at Visit 2a.

Exclusion Criteria

Known hypersensitivity/intolerance to ketamine or excipients.
Inability to swallow the IP whole.
Pregnant or lactating females.
Significant risk of suicide (C-SSRS items 4 or 5 positive, suicidal behaviour within past year, or clinically identified significant suicidal risk).
Current ongoing psychiatric/neurological conditions: MDD with psychotic features, schizophrenia spectrum or other psychotic disorders, bipolar disorder, other specified disorders; first-degree relatives with psychotic or bipolar disorders also excluded.
Certain personality disorders (paranoid, schizoid, antisocial, borderline, histrionic, narcissistic) and moderate–severe intellectual disability/autism spectrum as specified.
History of significant CNS disease, surgery, encephalitis, meningitis, degenerative CNS disorder, epilepsy (except uncomplicated childhood febrile seizures).
Significant head trauma within past 2 years.
History of cerebrovascular event or known/suspected cardiac disease or ECG abnormalities that jeopardise safety.
Family history of sudden cardiac death in first-degree relatives.
Untreated/uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥90 mmHg after 5 min rest).
Liver function abnormalities (ALT/AST/GGT/AP >2×ULN or total bilirubin >1.5×ULN) unless discussed with medical monitor.
Known hepatitis B or C.
eGFR <60 mL/min/1.73 m2 or creatinine >200 µmol/L, dialysis or kidney transplant.
Uncontrolled diabetes (HbA1c >8.0%).
Unstable thyroid disease as specified.
History (within 5 years) of complicated cystitis.
Previous administration of ketamine or esketamine within 1 year prior to Visit 1.
Moderate to severe alcohol use disorder or substance use disorder (except nicotine/caffeine) within 6 months or positive drug screen (except allowed meds).
Use of other investigational products within specified windows or participation in ≥2 MDD/psychiatric trials within 1 year.
Employees/family of investigator, sponsor, CRO or consultants; persons committed by judicial order.
Known or suspected eye globe injury or increased intraocular pressure (eg, glaucoma).

Company

Product

Legal

Detailed Description

Study Arms & Interventions

KET01 120 mg

Interventions

KET01 240 mg

Interventions

Locations

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details