Clinical TrialMajor Depressive Disorder (MDD)KetamineKetamineKetamineRecruiting

Pilot study evaluating the efficacy of subcutaneous ketamine for the treatment of depression in the elderly

This open-label trial (n=24) investigates the efficacy of subcutaneous ketamine (21-42mg/70kg) for treating depression (MDD) in elderly patients.

Target Enrollment
24 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, non-randomised, single-group Phase II study in older adults (≥65) with MDD (n=24). Phase 1: all participants receive subcutaneous ketamine 0.3 mg/kg then 0.6 mg/kg one week apart; responders may enter Phase 2 maintenance.

Primary outcome is change in Geriatric Depression Scale (GDS). Phase 2 maintenance dosing is individualised (1–2x/week up to 3 months). Safety and tolerability monitored throughout.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

SC ketamine

experimental

Phase 1: single subcutaneous doses 0.3 mg/kg then 0.6 mg/kg (1 week apart). Phase 2: responders offered maintenance dosing up to 3 months (1–2x/week).

Interventions

  • Ketamine0.3 mg/kg
    via Other• single dose• 1 doses total

    subcutaneous (SC) single dose (Phase 1)

  • Ketamine0.6 mg/kg
    via Other• single dose• 1 doses total

    subcutaneous (SC) single dose (Phase 1)

  • Ketamine
    via Other• 1-2 times per week

    Individualised subcutaneous maintenance dosing for responders for up to 3 months (Phase 2)

Participants

Ages
65 – 99
Sexes
Male & Female

Inclusion Criteria

  • To be included in the study, participants must meet all of the following inclusion criteria:
  • 1. Capable of understanding and signing an informed consent
  • 2. Aged > 65 years on the day of consent.
  • 3. Psychiatric history: Participants will be assessed using DSM-5 criteria (APA, 2013) via a standardized clinical psychiatric interview conducted by a trained examiner.
  • 4. Patients with MDD: Baseline GDS > 9.

Exclusion Criteria

  • To be included in the study, participants must meet none of the following exclusion criteria:
  • 1. Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved).
  • 2. Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
  • 3. Patients with severe unstable acute or chronic medical illnesses.
  • 4. Patients with current active suicidal ideation.
  • 5. Any history of an additional axis I diagnosis (not including adjustment disorder, simple phobia, dysthymia or comorbid anxiety) is exclusionary.

Study Details

Locations

Unknown facility — Australia

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