Study of Ketamine as an Antidepressant in Major Depressive Disorder
NCT ID: NCT01573741
Last Updated: 2012-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
35 participants
INTERVENTIONAL
2012-02-29
2013-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ketamine,four hours monitoring hydrochloride injection
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
Ketamine
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
Interventions
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Ketamine
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
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Shi Jinyun
OTHER
Responsible Party
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Shi Jinyun
Department of Anesthesiology, School of Medicine, Jinling Hospital, Nanjing
Principal Investigators
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Jianjun Yang, Dr
Role: STUDY_CHAIR
Department of Anesthesiology, Jinling Hospital, School of Medicine, Nanjing University
Locations
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The PLA 102nd Hospital and mental health center of military
Changzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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nju-030614
Identifier Type: -
Identifier Source: org_study_id
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