CompletedPhase 2ketamine

Ketamine as an Alternative Treatment to ECT in Major Depressive Disorder

NCT ID

NCT02659085

Target Enrollment

198 participants

Start Date

2015-02

Est. Completion

2019-08

About This Study

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).

Conditions Studied

Depressive Disorder, Major

Interventions

•Ketamine IV Infusion
•ECT

Eligibility

Age:18 Years - 85 Years

Healthy Volunteers:No

View full eligibility criteria

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

Study Locations (1)

Department of Psychiatry