Depressive Disorder, Major Clinical Trial
Official title:
A Randomized Controlled Non-inferiority Trial Comparing Ketamine With ECT in Patients With Major Depressive Disorder
Verified date | December 2019 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Developing more effective and faster acting antidepressant is of outmost clinical importance. Available antidepressant therapies have a delayed therapeutic effect. It typically takes several weeks before symptom relief is evident. Furthermore, antidepressants are relatively ineffective - as many as 30% of patients do not respond to any medication at all. In this study the investigators evaluate the NMDA-receptor antagonist ketamine as a potentially new antidepressant treatment for severely depressed patients and compare its effectiveness with that of electroconvulsive therapy (ECT).
Status | Completed |
Enrollment | 198 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Aged 18-85 - Diagnosed with major depressive disorder (MDD, according to DSM-IV) - Inpatients who have been offered and have accepted ECT - Are eligible to participate - Score = 20 Points on Montgomery Åsberg Depression Rating Scale (MADRS) - Must be proficient in spoken and written Swedish - American Society of Anaesthesiologists physical status classification (ASA) 1-3 Exclusion Criteria: - Co-morbid conditions that could interfere with the treatment (e.g. primary psychosis) - Habitual difficulties to speak, hear, remember or reason - Treatment according to LPT (Lagen om psykiatrisk tvångsvård; Compulsory Psychiatric Care Act) - On-going or recent (6 months) drug abuse - Known allergy to the active substance - Pregnant or breastfeeding women - Known cardiovascular disease, including angina, acute/chronic congestive heart failure, moderly hypertension or tachyarrhythmia (because exacerbation by sympathomimetic properties of ketamine) - Pathological conditions in central nervous system with risk of increased intracranial pressure (increased ICP with ketamine) - Glaucoma (increased IOP with ketamine) - Porphyria or thyroid disorder (enhanced sympathomimetic properties by ketamine) - Ongoing severe infection |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Psychiatry | Lund |
Lead Sponsor | Collaborator |
---|---|
Pouya Movahed Rad |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients in remission in each treatment arm assessed by Montgomery-Asberg Depression Rating Scale (MADRS) | Primary outcome is the proportion of patients in remission in each treatment arm. Remission is defined as a MADRS = 10. | Follow up of one year after treatment cessation | |
Secondary | Time to remission compared between the two treatments. | Time (days) to reach remission (defined as MADRS= 10) is compared between the groups. | The MADRS score is measured for a maximum of 4 weeks. | |
Secondary | Time to response compared between the two treatments. | Time (days) to response (defined as a drop of 50% from the pre-treatment MADRS value)) is compared between the groups. | The MADRS score is measured for a maximum of 4 weeks. | |
Secondary | Ketamine treatment is associated with a smaller decrease in the performance in a CANTAB cognitive test battery compared to ECT. | Cognitive function are assessed with Cambridge Automated Neuropsychological Test Automated Battery (CANTAB). | Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment. | |
Secondary | Remission from severe depression is associated with improved performance in the performance in a CANTAB cognitive test battery. | Cognitive function are assessed with Cambridge Automated Neuropsychological Test Automated Battery (CANTAB). | Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment. | |
Secondary | The antidepressant effect of ketamine is longer lasting than that of ECT, assessed by the proportion of patients in remission (defined by a maximum score of 9 in the Montgomery-Asberg Depression Rating Scale (MADRS)). | The antidepressant effect will be assessed with MADRS baseline score and measured within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment. | Within one week after remission and at three additional time points (3, 6 and 12 months) after remission | |
Secondary | Ketamine treatment is associated with a smaller decrease in the performance in Rey Auditory Verbal Learning Test (RAVLT) compared to ECT. | Reys Auditory Verbal Learning Test (RAVLT) | Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment. | |
Secondary | Remission from severe depression is associated with improved performance in the performance in Rey Auditory Verbal Learning Test (RAVLT). | Reys Auditory Verbal Learning Test (RAVLT) | Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment. |
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