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Study of Ketamine as an Antidepressant in Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Ketamine

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depressive ketamine antidepressant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The PLA 102nd Hospital and mental health center of militaryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ketamine,four hours monitoring hydrochloride injection

Arm Description

a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes

Outcomes

Primary Outcome Measures

all cause remission

Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation by MADRS,HDRS and SSI.

Secondary Outcome Measures

Full Information

NCT ID

NCT01573741

First Posted

April 5, 2012

Last Updated

May 2, 2012

Sponsor

Shi Jinyun

1. Study Identification

Unique Protocol Identification Number

NCT01573741

Brief Title

Study of Ketamine as an Antidepressant in Major Depressive Disorder

Official Title

Department of AnesthesiologyJinling Hospital, Nanjing University School of Medicine, Nanjing, China

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shi Jinyun

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

depressive ketamine antidepressant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ketamine,four hours monitoring hydrochloride injection

Arm Type

Experimental

Arm Description

a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes

Primary Outcome Measure Information:

Title

all cause remission

Description

Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation by MADRS,HDRS and SSI.

Time Frame

7day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qin zhi Gao, MD

Phone

051983064728

gzq_102@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Song bai ding, MD

Phone

051983064728

dingsongbai@sohu.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianjun Yang, Dr

Organizational Affiliation

Department of Anesthesiology, Jinling Hospital, School of Medicine, Nanjing University

Official's Role

Study Chair

Facility Information:

Facility Name

The PLA 102nd Hospital and mental health center of military

City

Changzhou

State/Province

Jiangsu

ZIP/Postal Code

213003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qin zhi Gao, MD

Phone

0519-83064728

gzq_102@hotmail.com

First Name & Middle Initial & Last Name & Degree

Bai song Ding, MD

12. IPD Sharing Statement

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Study of Ketamine as an Antidepressant in Major Depressive Disorder

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