CompletedPhase 1/2

Rapid Antidepressant Effects of Ketamine in Major Depression

United States67 participantsStarted 2004-07-26

Plain-language summary

Depressive disorders may be severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants. This study examines whether ketamine can cause a rapid-next day antidepressant effect in patients with Major Depressive Disorder. This study was designed to address the questions: Does the NMDA antagonist ketamine produce rapid antidepressant effects in patients with treatment-resistant major depression? What are the neurobiological correlates of antidepressant response (examining multi-modal MRI, MEG, polysomnography and serum markers) Patients, ages 18 to 65 years with treatment-resistant major (unipolar) depression will in a double-blind crossover study receive either intravenous ketamine or saline solution.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female subjects, 18 to 65 years of age.
✓. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
✓. Subjects must fulfill DSM-IV criteria for Major Depressive Disorder (MDD) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, SCID-P.
✓. Subjects must have an initial score of at least 20 on the MADRS at screen and at baseline of study phase I.
✓. Subjects must have failed to respond in the past to an adequate dose and duration of at least one antidepressant (SSRI, bupropion, or venlafaxine) during a depressive episode
✓. Current depressive episode of at least 4 weeks duration.
✓. Age of onset less than 40 years of age.
✓. Subjects with MDD must fulfill DSM-IV criteria for Major Depression single episode or recurrent without psychotic features based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P).

Exclusion criteria

What they're measuring

MADRS Score - Baseline

Timeframe: Baseline

MADRS Score - Day 1 Following Intervention

Timeframe: Day 1

Trial details

NCT IDNCT00088699

SponsorNational Institute of Mental Health (NIMH)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2017-07-31

Results submitted2018-07-30

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