Rapid Antidepressant Effects of Ketamine in Major Depression

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Depression, Mood Disorders, Major Depresssion

In brief

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.

Key facts

Study ID

NCT00088699

Run by

National Institute of Mental Health (NIMH)

People needed

67

Starts

2004-07-26

Expected to finish

2017-07-31

Last updated by the study team

2018-10-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• General patient exclusion criteria
• Current or past diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
• Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 3 months.
• Female subjects who are either pregnant or nursing.
• Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• Subjects with uncorrected hypothyroidism or hyperthyroidism.
• Subjects with one or more seizures without a clear and resolved etiology.
• Treatment with a reversible MAOI within 4 weeks prior to study phase I.
• Treatment with fluoxetine within 5 weeks prior to study phase I.
• Treatment with any other concomitant medication not allowed (Appendix A for Substudy 2; Appendix G for Substudy 4) 14 days prior to study phase I.
• No structured psychotherapy will be permitted during the study.
• Current NIMH employee/staff or their immediate family member.
• Additional Exclusion Criteria for substudy 2 (patients with MDD)
• Previous treatment with ketamine or hypersensitivity to amantadine.
• Additional Exclusion Criteria for Substudy 4 (patients with MDD)
• Subjects who currently are using drugs (except for caffeine or nicotine), must not have used illicit substances in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening.
• Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
• Clinically significant abnormal laboratory tests.
• For imaging procedures, Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).
• Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of >4.
• Exclusion Criteria for healthy control subjects (Substudy 4 only)
• Current or past Axis I diagnosis
• Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips).
• Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
• Treatment with any of the exclusionary medications detailed in Appendix G 14 days prior to Phase 1 of the Substudy 4.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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