Study of Ketamine as an Antidepressant in Major Depressive Disorder

NCT ID: NCT01573741

Last Updated: 2012-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ketamine,four hours monitoring hydrochloride injection

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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

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

Interventions

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Ketamine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shi Jinyun

OTHER

Sponsor Role lead

Responsible Party

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Shi Jinyun

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

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jianjun Yang, Dr

Role: STUDY_CHAIR

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

Locations

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The PLA 102nd Hospital and mental health center of military

Changzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qin zhi Gao, MD

Role: CONTACT

051983064728

Song bai ding, MD

Role: CONTACT

051983064728

Facility Contacts

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Qin zhi Gao, MD

Role: primary

0519-83064728

Other Identifiers

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nju-030614

Identifier Type: -

Identifier Source: org_study_id

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