Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation by MADRS,HDRS and SSI.
Study of Ketamine as an Antidepressant in Major Depressive Disorder
Brief Summary
Primary Outcome Measures:
Evaluate the changes in neuroimaging and biochemistry measures with ketamine treatment.
Secondary Outcome Measures:
Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation.
Intervention / Treatment
-
Ketamine (DRUG)a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
Condition or Disease
- Major Depressive Disorder
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 35 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Non-Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Feb 01, 2012 | |
|---|---|---|
| Primary Completion: | Dec 01, 2012 | ESTIMATED |
| Completion Date: | Feb 01, 2013 | ESTIMATED |
| Study First Posted: | Apr 09, 2012 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | May 02, 2012 |
Sponsors / Collaborators
Lead Sponsor:
Shi Jinyun
Responsible Party:
Shi Jinyun
Location
Participant Groups
-
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:Male patients, ages 18 to 65 years with a diagnosis of MDD, currently depressed or in a current major depressive episode of BD without psychotic features will be recruited into this substudy.
Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.
Exclusion Criteria:Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using oher antidepressant drugs 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.
Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
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.
Subjects with clinical hypothyroidism or hyperthyroidism.
Subjects with one or more seizures without a clear and resolved etiology.
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
Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.
Exclusion Criteria:Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using oher antidepressant drugs 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.
Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
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.
Subjects with clinical hypothyroidism or hyperthyroidism.
Subjects with one or more seizures without a clear and resolved etiology.
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
Primary Outcomes
More Details
| NCT Number: | NCT01573741 |
|---|---|
| Other IDs: | nju-030614 |
| Study URL: | https://clinicaltrials.gov/study/NCT01573741 |
Last updated: Sep 29, 2023