A multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3 week treatment period to assess the efficacy, safety and tolerability of add-on treatment with Ketamine hydrochloride prolonged release tablets (KET01, 120 mg or 240 mg once daily) in outpatients with treatment resistant depression

This double-blind, randomised, placebo-controlled Phase II trial (n=60) conducted in Germany by Ketabon explores the efficacy, safety, and tolerability of add-on treatment with ketamine prolonged-release tablets (KET01, 120 mg or 240 mg once daily) in outpatients with treatment-resistant depression (TRD).

The trial aims to assess the change in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score as the primary endpoint.

Participants (aged ≥ 18 and ≤ 65 years) with a primary diagnosis of major depressive disorder (MDD) meeting DSM-5 criteria and TRD criteria will undergo a 3-week treatment period. The trial involves controlled, randomised, and parallel-group designs, with a placebo group.

The trial’s primary objective is to explore the efficacy of KET01 as an add-on therapy compared to placebo, measuring improvements in depressive symptoms. Secondary objectives include investigating the safety, tolerability, and pharmacokinetics of KET01.

The trial concluded on an undisclosed date after being entered into the EudraCT database on December 3, 2021.

Sponsor’s Protocol Code Number: KET01-02).

You can also find the trial registered in the Czech Republic and Poland.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Germany
Visit trial
Status Completed
Results Published No
Start date 28 January 2022
End date 10 May 2023
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 60
Sex All
Age 18- 65
Therapy No

Trial Details

The EEA CTA trial in Germany studied Ketamine hydrochloride prolonged release tablets (KET01) as an add-on treatment for outpatients with treatment-resistant depression. It was a Phase II trial, double-blind and placebo-controlled, with a 3-week treatment period. The primary goal was to assess changes in MADRS scores, targeting subjects aged 18-65 with major depressive disorder.

NCT Number 2021-004927-34

Data attribution

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