Ketamine as an alternative to electrocolvulsive therapy for treatment of major depressive disorder

• Conditions: Major depression disorder; MedDRA version: 18.0Level: PTClassification code 10019063Term: HallucinationSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 18.0Level: PTClassification code 10013036Term: DiplopiaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 18.0Level: LLTClassification code 10061243Term: Post procedural nauseaSystem Organ Class: 100000004863; MedDRA version: 18.0Level: PTClassification code 10047343Term: Vertigo CNS originSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 18.0Level: LLTClassification code 10015533Term: EuphoriaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-001520-37-SE
• Lead Sponsor: Skåne University Hospital, Malmö

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-24
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

ASA grade 1-3
Age 18-65
Major depressive episode according to DSM-IV
Montgomery Asberg Depression Rating Scale (MADRS) = 20
Offered and accepted ECT
Understands and speaks swedish
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 194
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Reluctance to continued participation in the study
Inability to adequately participate in the study
Suspected serious adverse reaction
Known / suspected allergy to drugs to be used in the study
Comorbid psychiatric diagnosis that could interfere with treatment: primary psychotic disorder, personality disorder
Habitual speech, hearing, memory, or cognitive difficulties
Breastfeeding or anamnestic known / suspected pregnancy
Known / suspected ongoing or recent (within 6 months) drug abuse
Ongoing care of Compulsory Mental Care Act
Hypovolemia, dehydration or heart disease, especially coronary artery disease (eg, congestive heart failure, myocardial ischemia, and myocardial infarction) due to the significant increase in myocardial oxygen consumption.
Moderate hypertension and tachyarrhythmias
Elevated cerebrospinal pressure and injuries or diseases of the CNS.
Elevated intraocular pressure (e.g., glaucoma)
Acute intermittent porphyria.
Ongoing severe infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the antidepressant effect of subanaesthetic ketamine to ECT.;Secondary Objective: To further evaluate the safety of subanaesthetic ketamine regarding psychotic symptoms<br>To investigate neurocognitive side effects of the two treatments, memory and executive functions in particular;Primary end point(s): Antidepressive effect;Timepoint(s) of evaluation of this end point: The assessment is made before, and 4-5 hours after the first treatment. Subsequent assessments are made 1 or 2 days after each treatment session, and within one week after remission. A major evaluation occurs after 6 treatments to determine continued participation in the study.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Depressive symptoms<br>Anxiety Symptoms<br>Psychotic Symptoms<br>cognition<br>Suicide Risk<br>Concerns and expectations;Timepoint(s) of evaluation of this end point: Depressive symptoms: before, and 4-5 hours after the first treatment, then 1 or 2 days after each treatment session, and within one week after remission, plus 2, 6, and 12 months after remission.<br>Psychotic symptoms: before treatment, 1 and 4-5 hours after, and 1 or 2 days after the first treatment, the sixth treatment and the last treatment.<br>Anxiety symptoms: same as for depressive symptoms.<br>Cognition: Before the first treatment, after the 6th and the last treatment, and at 2, 6 and 12 months after remission.<br>Suicide: In connection to each evaluation<br>Concerns and expectations: Before the first treatment, and after the 6th and the last treatment.