Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboCompleted

A multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3 week treatment period to assess the efficacy, safety and tolerability of add-on treatment with Ketamine hydrochloride prolonged release tablets (KET01, 120 mg or 240 mg once daily) in outpatients with treatment resistant depression

Randomised, double-blind, placebo-controlled Phase II trial (n=180 planned) assessing once-daily KET01 prolonged-release ketamine tablets (120 mg or 240 mg) versus placebo as add-on therapy in outpatients with treatment-resistant depression.

Ask Blossom about this trial
Target Enrollment
180 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Continue exploring

Continue exploring this trial

Move from the registry record to the most relevant public research context.

Compound research: KetamineTopic research: Treatment-Resistant Depression (TRD)Research in Germany

Detailed Description

Multicentre, double-blind, randomised parallel-group Phase II trial evaluating the efficacy and safety of KET01 120 mg or 240 mg once daily versus matched placebo as add-on treatment for subjects with treatment-resistant major depressive disorder.

Primary outcome is change in MADRS total score from baseline to end of treatment; secondary outcomes include response/remission rates, HAM-D17, CGI-S, quality of life measures, sleep indices, dissociation (CADSS), vital signs and population pharmacokinetics of ketamine and metabolites.

Study Arms & Interventions

KET01 120 mg

experimental

KET01 prolonged-release tablet 120 mg once daily as add-on to standard antidepressant therapy for 3 weeks.

Interventions

  • Ketamine120 mg
    via Oral• once daily• 21 doses total

    120 mg KET01 OD for 3 weeks

KET01 240 mg

experimental

KET01 prolonged-release tablet 240 mg once daily as add-on to standard antidepressant therapy for 3 weeks.

Interventions

  • Ketamine240 mg
    via Oral• once daily• 21 doses total

    240 mg KET01 OD for 3 weeks

Placebo (matched to KET01)

inactive

Prolonged-release matching placebo tablet once daily for 3 weeks.

Interventions

  • Placebo
    via Oral• once daily• 21 doses total

    Matching prolonged-release placebo OD for 3 weeks

Participants

Ages
18 – 65
Sexes
Male & Female

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).

Study Protocol, Arms & Participants

Go Pro to access detailed study protocol timelines, treatment arms, dosing schedules, and participant eligibility criteria.

See Pro Plans

Study Details

Locations

Germany

Recent activity

  • CompletedA multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3 week treatment per… (2021-004927-34, ketamine)
  • StartedA multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3 week treatment per… (2021-004927-34, ketamine)

Your Personal Research Library

Go Pro to save trials, add notes, rate research, and organize custom shelves.

See Pro Plans