Clinical TrialDepressive DisordersKetaminePlaceboCompleted

Ketamine’s Actions on Rumination Mechanisms as an Antidepressant

Double-blind, randomised crossover fMRI study (n=37) testing a single IV ketamine infusion (0.5 mg/kg over 40 min) versus saline in remitted depressed volunteers to examine early antidepressant effects on rumination and reward-related brain activity.

Target Enrollment
37 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

This double-blind, randomised crossover study examines acute (2-hour) antidepressant effects of a single 0.5 mg/kg IV ketamine infusion versus saline in remitted depressed participants using fMRI tasks probing autobiographical emotional memory (rumination) and monetary reward (anhedonia).

Outcomes include changes in limbic and striatal activation during tasks, with secondary assessment of safety and tolerability; sessions are separated by a minimum 1-week washout.

Study Protocol

Preparation

sessions

Dosing

2 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketalar

experimental

Ketalar (ketamine) single intravenous steady-state infusion over 40 min.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Single IV infusion over 40 minutes (0.5 mg/kg).

Saline

inactive

Intravenous saline placebo comparator, steady-state infusion over 40 min.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Saline IV infusion over 40 minutes (placebo comparator).

Participants

Ages
18 – 50
Sexes
Male & Female

Inclusion Criteria

  • Right-handed male and female volunteers with a history of depression between the ages of 18 and 50 years.
  • Good command of the English language.
  • Evidence of a personally signed and dated informed consent document.
  • Willing and able to comply with scheduled visits, dosing plan, laboratory trials and other necessary procedures.
  • Willing for anonymised data to be shared and disseminated.

Exclusion Criteria

  • Current or previously diagnosed psychiatric disorder except depression.
  • One or more immediate family members with a current or previously diagnosed psychotic disorder.
  • Medically significant condition rendering subject unsuitable (e.g., diabetes, severe cardiovascular disease, hepatic or renal failure).
  • MR contraindications (metal implants, pacemaker, claustrophobia).
  • Previous adverse response to ketamine.
  • Excessive use of alcohol (>28 units/week), caffeine (>6 cups/day), or other drugs.
  • Use of medications not discussed with investigators (exceptions noted in protocol).
  • Illicit drugs within 7 days prior to admission; alcohol or caffeine within 24 hours; nicotine within 4 hours.
  • Grapefruit juice or Seville orange products within 24 hours prior to admission.
  • Prescribed medication within 3 weeks prior to enrolment (or non-prescription medication/herbal within 7 days) except as allowed.
  • Significant history of drugs of abuse or positive drug screen.
  • Acute illness within 2 weeks before study start.
  • Clinically significant abnormalities in chemistry, haematology or urinalysis.
  • History or presence of gastrointestinal, hepatic or renal disease likely to interfere with drug handling.
  • Diagnosed hypertension or supine BP outside 90–140/40–90 mmHg after acclimatisation.
  • Orthostatic hypotension (drop in systolic >25 mmHg or diastolic >15 mmHg on standing).
  • Treatment in previous 3 months with drugs known for hepatotoxicity.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment37 participants
  • Timeline
    Start: 2014-01-09
    End: 2018-01-05
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

United Kingdom

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