Study of Ketamine as an Antidepressant in Major Depressive Disorder

NCT01573741 | Unknown Phase 1 DMC

• 1 other identifier: nju-030614
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

depressive ketamine antidepressant

Outcome Measures

Primary Outcomes (1)

• 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.

  7day

Study Arms (1)

ketamine,four hours monitoring hydrochloride injection

EXPERIMENTAL

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

Drug: Ketamine

Interventions

Ketamine DRUG

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

ketamine,four hours monitoring hydrochloride injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shi Jinyun: lead

Study Sites (1)

The PLA 102nd Hospital and mental health center of military

Changzhou, Jiangsu, 213003, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jianjun Yang, Dr

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

  STUDY CHAIR

Central Study Contacts

Qin zhi Gao, MD

CONTACT

051983064728; gzq_102@hotmail.com

Song bai ding, MD

CONTACT

051983064728; dingsongbai@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology, School of Medicine, Jinling Hospital, Nanjing

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 9, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 4, 2012

Record last verified: 2012-04

Locations

CN (1)