Clinical TrialTreatment-Resistant Depression (TRD)KetamineCompleted

A Preliminary Study of Intravenous Ketamine in Selective Serotonin Reuptake Inhibitor (SSRI)-Resistant Depression

This completed interventional, single-site Phase II study (n=20) evaluated intravenous ketamine given weekly for three weeks in patients with SSRI‑resistant depression.

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

Detailed Description

This single-site, non-randomised Phase II trial enrolled 20 patients with SSRI‑resistant major depression to receive intravenous ketamine once weekly for three weeks.

The primary outcome was change in depressive symptoms assessed two weeks after the final infusion; secondary objectives included measurement of biomarkers (cytokines, tryptophan metabolism and endocrine parameters) pre- and post-treatment and at longer-term follow-up.

Sponsor was the Department of Psychiatry, University College Cork; IMP was ketamine hydrochloride (Ketalar), provided by Pfizer Healthcare Ireland.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

IV ketamine

experimental

Intravenous ketamine administered weekly for three weeks in SSRI‑resistant depression (single-site, non-randomised).

Interventions

  • Ketamine
    via IV• weekly for 3 doses• 3 doses total

    Per-infusion dose not specified in registry; IMP concentration listed as '10' in EudraCT record (unit unclear).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Be able to give written informed consent
  • Aged 18 to 65 years, male or female
  • DSM‑IV major depression with a Hamilton Depression Rating Scale score greater than 17
  • Failed an adequate trial of an SSRI antidepressant at an adequate dose for at least 6 weeks

Exclusion Criteria

  • Age less than 18 or greater than 65
  • Significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, immunological, or any condition which, in the investigator's judgement, contraindicates entry to the study)
  • Condition or medication that would interfere with the objectives of the study, pose a safety risk or confound interpretation of results (to include anti-inflammatory medications such as aspirin and systemic steroids)
  • Evidence of immunodeficiency, bleeding disorder or coagulopathy
  • Pregnancy
  • Family or personal history of psychosis

Study Details

Locations

Ireland

Your Library