Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088699
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2004-07-30
Brief Title:
Rapid Antidepressant Effects of Ketamine in Major Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigation of the Rapid Next Day Antidepressant Effects of an NMDA Antagonist
Status:
COMPLETED
Status Verified Date:
2017-07-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 medications are effective for treating depression however they take weeks or months to achieve their full effects A more rapidly acting antidepressant would have a significant impact on the treatment of depression In a previous study ketamine produced a rapid antidepressant effect within hours but the effect lasted less than 1 week Understanding how ketamine works may lead to a better understanding of the causes of depression and the design of a longer lasting rapidly acting antidepressant
Patients between 18 and 65 years of age who are currently experiencing an episode of major depression of at least 4 weeks duration and have not responded to two treatment trials may be eligible for this study Candidates are screened with a medical and psychiatric history physical examination and blood and urine tests
Participants undergo the following tests and procedures
Medication tapering Patients who are taking medications for depression are tapered off the drugs over a 1- to 2-week period
Ketamineplacebo trial Patients are given a single dose of either ketamine or placebo an inactive substance administered intravenously through a vein over 40 minutes After 7 days patients are given another dose of study drug in crossover fashion that is those who previously took ketamine are switched to receive placebo and those who took placebo are switched to ketamine Oximetry measurement of blood oxygen pulse and blood pressure are measured continuously for 1 hour before and 4 hours after each ketamine or placebo dose to monitor safety
Interviews and rating scales Patients complete a series of psychiatric rating scales to assess the effects of the study drug on mood and thinking The rating scales are repeated up to 18 times during the study with each time taking about 15 to 20 minutes
Physical examination and laboratory tests Patients have a physical examination blood tests weight measure and electrocardiogram ECG at the beginning and end of the study They will also have multi-modal MRI MEG polysomnography and serum marker studies
The primary endpoint will be the change in clinical ratings of depression Secondary endpoints will examine neurobiological correlates ie multi-modal MRI MEG polysomnography and serum markers of antidepressant response to ketamine compared to placebo
Patients between 18 and 65 years of age who are currently experiencing an episode of major depression of at least 4 weeks duration and have not responded to two treatment trials may be eligible for this study Candidates are screened with a medical and psychiatric history physical examination and blood and urine tests
Participants undergo the following tests and procedures
Medication tapering Patients who are taking medications for depression are tapered off the drugs over a 1- to 2-week period
Ketamineplacebo trial Patients are given a single dose of either ketamine or placebo an inactive substance administered intravenously through a vein over 40 minutes After 7 days patients are given another dose of study drug in crossover fashion that is those who previously took ketamine are switched to receive placebo and those who took placebo are switched to ketamine Oximetry measurement of blood oxygen pulse and blood pressure are measured continuously for 1 hour before and 4 hours after each ketamine or placebo dose to monitor safety
Interviews and rating scales Patients complete a series of psychiatric rating scales to assess the effects of the study drug on mood and thinking The rating scales are repeated up to 18 times during the study with each time taking about 15 to 20 minutes
Physical examination and laboratory tests Patients have a physical examination blood tests weight measure and electrocardiogram ECG at the beginning and end of the study They will also have multi-modal MRI MEG polysomnography and serum marker studies
The primary endpoint will be the change in clinical ratings of depression Secondary endpoints will examine neurobiological correlates ie multi-modal MRI MEG polysomnography and serum markers of antidepressant response to ketamine compared to placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-M-0222 | None | None | None |