Study of Ketamine as an Antidepressant in Major Depressive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Jinling Hospital, China.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shi Jinyun, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01573741
First received: April 5, 2012
Last updated: May 2, 2012
Last verified: April 2012
  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

Resource links provided by NLM:


Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
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

ClinicalTrials.gov processed this record on September 14, 2014