The Role of mTOR (Mammalian Target of Rapamycin) Signaling Pathway in the Antidepressive Effect of Ketamine in Patients with Depressive Disorder

This single-blind, placebo-controlled crossover trial (n=30), sponsored by Prague Psychiatric Centre, aimed to investigate the role of the mTOR (Mammalian Target of Rapamycin) signalling pathway in the anti-depressive effect of ketamine in patients with depression (MDD).

The study involved adults aged 18 to 65 with major depressive episodes, excluding those with psychotic symptoms. The primary objective was to assess whether mTOR activity, brain parameters, and changes induced by ketamine differed between responders and non-responders.

The trial used ketamine hydrochloride (trade name: CALYPSOL) as the investigational medicinal product, administered through intravenous infusion. The trial, part of a Therapeutic Confirmatory (Phase III) study, had a single-blind, crossover design, with a total planned duration of 2 years in the Czech Republic. The trial, ending on December 31, 2015, was authorized by the Competent Authority on April 25, 2013, and received a favourable Ethics Committee Opinion on April 29, 2013.

(EudraCT Number: 2013-000952-17; Protocol Code: NT13403)

Topic Depression
Compound Ketamine
Country Czech Republic
Visit trial
Status Completed
Results Published No
Start date 25 April 2013
End date 31 December 2015
Phase Phase III
Design Blinded
Type Interventional
Generation Second
Participants 30
Sex All
Age 18- 65
Therapy No

Trial Details

This single-blind, placebo-controlled crossover trial (n=30) investigated the role of the mTOR signaling pathway in the antidepressive effect of ketamine in adults with major depressive episodes. Sponsored by Prague Psychiatric Centre, the study used ketamine hydrochloride (CALYPSOL) through intravenous infusion. The primary objective was to assess differences in mTOR activity and brain parameters between responders and non-responders. The trial, part of a Therapeutic Confirmatory (Phase III) study, lasted from March 12, 2013, to December 31, 2015, in the Czech Republic, with authorization from the Competent Authority on April 25, 2013, and a favourable Ethics Committee Opinion on April 29, 2013.

Trial Number 2013-000952-17

Data attribution

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