Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboWithdrawn

Ketamine in treatment-resistant major depression

Randomised, placebo-controlled parallel-group multi-centre trial (n=100; withdrawn) testing a single IV ketamine infusion (0.5 mg/kg over 40 minutes) versus saline placebo in treatment-resistant major depression.

Target Enrollment
100 participants
Study Type
Phase NA interventional
Design
Randomized

Detailed Description

Randomised, placebo-controlled parallel-group design enrolling 100 participants with treatment-resistant depression to receive a single IV ketamine infusion (0.5 mg/kg over 40 minutes) or 0.9% saline placebo.

Primary outcome is change in HAMD-17 scores during the first seven days after infusion compared with baseline; secondary measures include quality-of-life (15-D), HAMD/Melancholia Scale, and SCL-90.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV ketamine infusion (active)

Interventions

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

    Infusion given over 40 minutes

Placebo

inactive

Normal saline placebo infusion

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    0.9% NaCl infusion over 40 minutes

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • 1. Major depression disorder (DSM-IV 296.2 or 296.3) or type two bipolar affective disorder, last phase with depressive symptoms
  • 2. Depressive symptoms at least at moderate level (HAMD-17 score ≥16)
  • 3. Age 18 to 55 years
  • 4. Insufficient response to at least two different antidepressants
  • 5. No substantial changes in current antidepressant treatment during the last four weeks and no planned changes for the following two weeks

Exclusion Criteria

  • 1. Serious somatic disease (cardiac insufficiency, untreated hypertension, increased cerebral pressure, CNS diseases, increased intraocular pressure (glaucoma), hepatic disease, porphyria, thyroid disease, lung infection, upper respiratory tract infection, epilepsy)
  • 2. Theophylline medication, or use of anticonvulsants or drugs affecting glutamatergic system
  • 3. Proneness to psychotic symptoms (psychosis diagnosed in first-degree relatives)
  • 4. Increased suicide risk
  • 5. Pregnancy
  • 6. Substance abuse during the last three weeks
  • 7. Exceptionally large dosage of antidepressants (dosage per day more than recommended in Pharmaca Fennica) (amended 19/12/2006)
  • 8. Exceptionally large dosage of benzodiazepines (diazepam equivalent dose >30 mg/day)

Study Details

Locations

Niuvanniemi Hospital — Kuopio, Finland

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