Study of Ketamine as an Antidepressant in Major Depressive Disorder
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Ketamine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Department of AnesthesiologyJinling Hospital, Nanjing University School of Medicine, Nanjing, China |
- all cause remission [ Time Frame: 7day ] [ Designated as safety issue: No ]Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation by MADRS,HDRS and SSI.
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ketamine,four hours monitoring hydrochloride injection
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
|
Drug: Ketamine
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Qin zhi Gao, MD | 051983064728 | gzq_102@hotmail.com |
| Contact: Song bai ding, MD | 051983064728 | dingsongbai@sohu.com |
| China, Jiangsu | |
| The PLA 102nd Hospital and mental health center of military | Recruiting |
| Changzhou, Jiangsu, China, 213003 | |
| Contact: Qin zhi Gao, MD 0519-83064728 gzq_102@hotmail.com | |
| Sub-Investigator: Bai song Ding, MD | |
| Study Chair: | Jianjun Yang, Dr | Department of Anesthesiology, Jinling Hospital, School of Medicine, Nanjing University |
More Information
No publications provided
| Responsible Party: | Shi Jinyun, Department of Anesthesiology, School of Medicine, Jinling Hospital, Nanjing, Jinling Hospital, China |
| ClinicalTrials.gov Identifier: | NCT01573741 History of Changes |
| Other Study ID Numbers: | nju-030614 |
| Study First Received: | April 5, 2012 |
| Last Updated: | May 2, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Jinling Hospital, China:
|
depressive ketamine antidepressant |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Antidepressive Agents Ketamine Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anesthetics, Dissociative |
Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013