Major depression disorder MedDRA version: 18.0 Level: PT Classification code 10019063 Term: Hallucination System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 18.0 Level: PT Classification code 10013036 Term: Diplopia System Organ Class: 10015919 - Eye disorders MedDRA version: 18.0 Level: LLT Classification code 10061243 Term: Post procedural nausea System Organ Class: 100000004863 MedDRA version: 18.0 Level: PT Classification code 10047343 Term: Vertigo CNS origin System Or
Conditions
Interventions
Product Name: ketamine
Product Code: ketamine
Pharmaceutical Form: Concentrate and solvent for solution for injection
Sponsors
Skåne University Hospital, Malmö
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Depressive symptoms Anxiety Symptoms Psychotic Symptoms cognition Suicide Risk 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. 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. Anxiety symptoms: same as for depressive symptoms. Cognition: Before the first treatment, after the 6th and the last treatment, and at 2, 6 and 12 months after remission. Suicide: In connection to each evaluation Concerns and expectations: Before the first treatment, and after the 6th and the last treatment. | — |
Primary
| Measure | Time frame |
|---|---|
| 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 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. | — |
Countries
Sweden
Contacts
Public ContactIda Ellerström
Skåne University Hospital Malmö
Outcome results
None listed