This open-label study aims to test the long-term safety, tolerability and effectiveness of repeated administration of IV, nasal spray and oral ketamine for treatment-resistant mood disorders.
Topic Depression
Bipolar Disorder
Compound Ketamine
Country Poland
Visit trial
Status
Recruiting
Results Published
Start date
04 December 2019
End date
31 December 2022
Chance of happening
100%
Phase
Not Applicable
Design
Open
Type
Interventional
Generation
First
Participants
120
Sex
All
Age
18- 90
Therapy
No
Trial Details
Current pharmacological treatments for depression prove unsatisfactory efficacy with a proportion of subjects demonstrating treatment-resistant depression (TRD). The observation applies both to major depressive disorder (MDD) as well as bipolar I depression. There is growing evidence that the glutamatergic system plays a role in the pathophysiology and treatment of depression. Discovery of rapid, although transient antidepressant effect of ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist used in a single sub-anaesthetic intravenous dose in unipolar, bipolar and treatment-resistant patients provides evidence for a glutamatergic antidepressant. Subsequent studies confirmed this effect in repeated doses. Further research demonstrated that repeated ketamine infusions result in sustainable antidepressant effect with both, twice-weekly and thrice-weekly administration schedules. However, the worsening of depression may occur after infusions are completed. Given the risk of relapses, there is a definite need for the development of new strategies to maintain the beneficial effects of ketamine treatment. In the present study, the investigators aim to openly assess the safety, tolerability, and effectiveness of repeated, individually tailored IV, nasal spray and oral ketamine for treatment-resistant mood disorders. The investigators intend to explore questions regarding optimal dose, treatment frequency and duration.NCT Number NCT04226963
Sponsors & Collaborators
Medical University of GdanskThe Medical University of Gdańsk is the largest medical academic institution in northern Poland.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.
Clinical-Administered Dissociative Symptoms Scale
The Clinical-Administered Dissociative Symptoms Scale (CADSS) is a scale used to measure dissociative states such as those induced by ketamine.