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Study of Ketamine as an Antidepressant in Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01573741
Recruitment Status : Unknown
Verified April 2012 by Shi Jinyun, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : April 9, 2012
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Ketamine Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Department of AnesthesiologyJinling Hospital, Nanjing University School of Medicine, Nanjing, China
Study Start Date : February 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. all cause remission [ Time Frame: 7day ]
    Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation by MADRS,HDRS and SSI.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573741


Contacts
Contact: Qin zhi Gao, MD 051983064728 gzq_102@hotmail.com
Contact: Song bai ding, MD 051983064728 dingsongbai@sohu.com

Locations
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         
Sponsors and Collaborators
Shi Jinyun
Investigators
Study Chair: Jianjun Yang, Dr Department of Anesthesiology, Jinling Hospital, School of Medicine, Nanjing University
More Information

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
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: April 2012

Keywords provided by Shi Jinyun, Jinling Hospital, China:
depressive ketamine antidepressant

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Antidepressive Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Psychotropic Drugs