Loading clinical trials...

Continuation Ketamine in Major Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Continuation Ketamine in Major Depression

Continuation Intravenous Ketamine in Major Depressive Disorder - Modification: Lithium for Relapse Prevention

NCT00548964•James Murrough

Summary

As of May 21st, 2012, the purpose of this study is to test the antidepressant effect of ketamine when given repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention strategy for patients with treatment-resistant depression (TRD) who respond to an initial series of ketamine infusions. Ketamine is a Food and Drug Administration approved anesthetic (a drug used to produce loss of consciousness before and during surgery). Ketamine is not approved for the treatment of major depressive disorder and is considered experimental in this study.

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients, 21-80 years of age;
•Female individuals who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or using a medically accepted reliable means of contraception. Women using oral contraceptive medication for birth control must also be using a barrier contraceptive. Women of childbearing potential must also have a negative serum B-HCG at screening and at pre-infusion;
•Participants must fulfill DSM-IV criteria for Major Depression without psychotic features, based on clinical assessment by a study psychiatrist and confirmed by a structured diagnostic interview, the Structured Clinical Interview for DSM-IV TR Axis I Disorders, Patient Edition (SCID-P);
•Participants must have a history of at least one previous episode of depression prior to the current episode (recurrent MDD) or have chronic MDD (of at least two years' duration);
•Participants have not responded to two or more adequate trials of an antidepressant as determined by Antidepressant Treatment History Form (ATHF) criteria (score \>=3);
•Participant scores on the IDS-C30 must be greater than or equal to 32;
•Current major depressive episode is of at least 4 weeks duration;
•Each participant must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
•Each participant must be able to identify a family member, physician, or friend who will participate in the Treatment Contract.

Exclusion Criteria

•Lifetime history of psychotic features, diagnosis of schizophrenia or any other psychotic disorder, or diagnosis of bipolar disorder;
•Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
•Current diagnosis of OCD or eating disorder (bulimia nervosa or anorexia nervosa);
•Subjects with DSM-IV drug or alcohol abuse/dependence within the preceding 2 years;
•Patients with schizotypal or antisocial personality disorder, or any clinically significant axis II disorder that would, in the investigator's judgment, preclude safe study participation;
•Patients judged clinically to be at serious and imminent suicidal or homicidal risk;
•Women who are either pregnant or nursing;
•Serious, unstable medical illnesses including hepatic, renal impairment, gastroenterologic (including gastro-esophageal reflux disease), respiratory (including obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics), cardiovascular (including ischemic heart disease and uncontrolled hypertension), endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
•Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
•Patients who have a positive urine toxicology for illicit substances at screening and within 24 hours of the infusion;
+10 more criteria

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

May 23, 2014

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Lithium

DRUG

Ketamine

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

View study

RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Continuation Ketamine in Major Depression

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use