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Study of Ketamine as an Antidepressant in Major Depressive Disorder

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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):
Shi Jinyun, Jinling Hospital, China

Tracking Information
First Submitted Date  ICMJE April 5, 2012
First Posted Date  ICMJE April 9, 2012
Last Update Posted Date May 4, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Ketamine as an Antidepressant in Major Depressive Disorder
Official Title  ICMJE Department of AnesthesiologyJinling Hospital, Nanjing University School of Medicine, Nanjing, China
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Ketamine
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
Study Arms  ICMJE Experimental: ketamine,four hours monitoring hydrochloride injection
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 6, 2012)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01573741
Other Study ID Numbers  ICMJE nju-030614
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shi Jinyun, Jinling Hospital, China
Study Sponsor  ICMJE Shi Jinyun
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jianjun Yang, Dr Department of Anesthesiology, Jinling Hospital, School of Medicine, Nanjing University
PRS Account Jinling Hospital, China
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP