Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboCompleted

Ketamine in treatment resistant major depression (TRD)

This double-blind, placebo-controlled therapeutic exploratory trial (n=80) investigates the effectiveness of a single intravenous application of ketamine at subanaesthetic doses in patients with treatment-resistant major depression (TRD).

Target Enrollment
80 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, placebo-controlled Phase II study assessing single i.v. subanaesthetic ketamine infusion for treatment-resistant major depression (n=80). Primary outcome is improvement on HAMD at 24 hours post-infusion.

Secondary objectives include testing pretreatment pgACC regional homogeneity (ReHo), functional connectivity and glutamine concentrations by MR as predictors of treatment response; MR spectroscopy measures at baseline, 60 minutes and 24 hours are included.

The trial was conducted as a single-site study in Germany with protocol MD-KPSY-01/10 and funded in part by the DFG; healthy control data were collected for biomarker comparisons.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine

experimental

Single intravenous subanaesthetic ketamine infusion (therapeutic arm).

Interventions

  • Ketamine
    via IV• single dose

    Single i.v. infusion at subanaesthetic dose (exact dose per protocol).

Placebo

inactive

Matched intravenous placebo comparator.

Interventions

  • Placebo
    via IV• single dose

    Solution for injection/infusion matched to ketamine.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Age 18–55 years; recurrent major depressive disorder for at least 5 years; on a stable regimen of psychotropic medications for >6 weeks prior to study entry; HAMD-21 score ≥18; failed responses to at least two previous adequate treatment attempts during the current episode. Treatment resistance defined by unsuccessful adequate trials (>6 weeks at maximum recommended or tolerated dose) of primary antidepressant drugs from at least three different classes, or unsuccessful adequate trials (>4 weeks) of augmentation/combination strategies using a primary antidepressant with at least two other different agents. Treatment resistance will be quantified after inclusion using the Antidepressant Treatment History Form (ATHF).

Exclusion Criteria

  • Pregnancy or breastfeeding; history of psychotic symptoms; increased intraocular pressure; known neurological comorbidities; cardiac exclusions including arterial hypertension, arrhythmia, congenital heart failure, heart insufficiency (NYHA II or higher), and coronary heart disease; any history of substance abuse or psychiatric comorbidities requiring additional treatment; known adverse responses to anaesthesia (e.g., postoperative delirium); MR-specific exclusions for biomarker substudies including metal implants, claustrophobia, certain tattoos and severe tinnitus.

Study Details

Locations

Germany

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