Status:
COMPLETED
Rapid Antidepressant Effects of Ketamine in Major Depression
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Mood Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
This study will test whether a single dose of ketamine - a drug that blocks a brain receptor called NMDA - can cause a rapid (next day) antidepressant effect in patients with major depression. Several...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- General patient 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.
- Additional inclusion criteria for substudy 4 (patients with MDD)
- 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).
- A failed adequate trial of ECT would count as an adequate antidepressant trial.
- In women of childbearing age, a negative pregnancy test within 24 hours of MRI.
- Inclusion criteria for healthy control subjects (Substudy 4 only)
- Age 18-65 years.
- Written informed consent completed.
- EXCLUSION CRITERIA:
- 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)
- 1\. 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.
- Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine).
- Presence of psychiatric disorders in first-degree relatives.
- Female subjects who are either pregnant or nursing.
- 8.Current NIMH employee/staff or their immediate family member.
Exclusion
Key Trial Info
Start Date :
July 26 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2017
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00088699
Start Date
July 26 2004
End Date
July 31 2017
Last Update
October 12 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892