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

  • Phase 1
  • Phase 2
  • 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

    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

    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

    Primary Outcomes
    • Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation by MADRS,HDRS and SSI.

    More Details

    NCT Number: NCT01573741
    Other IDs: nju-030614
    Study URL: https://clinicaltrials.gov/study/NCT01573741
    Last updated: Sep 29, 2023