Major Depressive Disorder
Conditions
Keywords
depressive ketamine antidepressant
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.
Interventions
DRUGKetamine
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
Sponsors
Shi Jinyun
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all cause remission | 7day | Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation by MADRS,HDRS and SSI. |
Countries
China
Contacts
Primary ContactQin zhi Gao, MD
Backup ContactSong bai ding, MD
Outcome results
None listed