Ketamine Co-induction for Patients With Major Depressive Disorder

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy

NCT01935115

Treatment Resistant Depression

COMPLETED PHASE4

Ketamine As an Adjunctive Therapy for Major Depression (2)

NCT04939649

Major Depressive Episode Unipolar Depression Bipolar Depression

COMPLETED PHASE3

Effects of Low-dose Ketamine as an Adjunct to Propofol-based Anesthesia for Electroconvulsive Therapy

NCT02579642

Depressive Disorder

COMPLETED PHASE4

Ketamine Anesthesia for Improvement of Depression in ECT

NCT02752724

Major Depressive Disorder

COMPLETED NA

Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial

NCT05233566

Postoperative Depression

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ketamine Depression Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Arm

As part of the patient's anesthetic induction, they will receive propofol and fentanyl.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

As part of the patient's anesthetic induction, they will receive propofol.

Fentanyl

Intervention Type DRUG

As part of the patient's anesthetic induction, they will receive fentanyl.

Ketamine Arm

As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.

Group Type ACTIVE_COMPARATOR

Ketamine Hydrochloride

Intervention Type DRUG

As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.

Propofol

Intervention Type DRUG

As part of the patient's anesthetic induction, they will receive propofol.

Fentanyl

Intervention Type DRUG

As part of the patient's anesthetic induction, they will receive fentanyl.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine Hydrochloride

As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.

Intervention Type DRUG

Propofol

As part of the patient's anesthetic induction, they will receive propofol.

Intervention Type DRUG

Fentanyl

As part of the patient's anesthetic induction, they will receive fentanyl.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of major depressive disorder
* Presentation for gynecologic surgery requiring a general anesthetic

Exclusion Criteria

* Marked co-morbid cardiovascular disease
* Marked co-morbid respiratory disease
* History of intracranial hypertension
* History of seizures
* ASA Physical Status Classification IV or greater
* History of psychosis
* Current pregnancy
* Contraindication to ketamine administration

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No