Ketamine in treatment-resistant major depression

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.

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

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)

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Detailed Description

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Dosing

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Ketamine

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Placebo

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Participants

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Study Details