This completed therapeutic exploratory Phase II trial of ketamine for treatment-resistant depression (TRD) and bipolar disorder (BD), was conducted in Belgium by UZ Leuven, a non-commercial sponsor.
The trial aimed to explore the efficacy and safety of intravenous ketamine in treating treatment-resistant depression (TRD) and bipolar disorder I and II. The primary objective was to replicate the efficacy of intravenous ketamine in TRD patients in a Belgian sample. The secondary objectives included distinguishing responders to ketamine from non-responders using different biological markers and identifying markers of relapse after the improvement of depressive symptoms.
The trial involved adults aged 18 and above and employed a randomised, double-blind, placebo-controlled design with a parallel-group structure. The study had 120 participants, with 50 in the age range of 18-64 years and 30 in the elderly age group (65 years and above). Both male and female participants were included. The trial used ketamine (Ketalar by Pfizer) as the investigational medicinal product (IMP), administered intravenously, with a placebo (solution for injection/infusion) also employed.
The primary endpoint was the relief of depressive symptoms, evaluated at various timepoints, including screening, after ketamine injection, final visit, and follow-up. Secondary endpoints included the Experience Sampling Method, predictors of response and relapse (biomarkers), and psychophysiology of stress. The trial did not involve subjects under 18, and it had no plans for treatment or care after the subject’s participation, apart from standard care.
The trial duration in the concerned Member State (Belgium) was two years. The study was authorised by the competent authority on July 27, 2016, and the ethics committee provided a favourable opinion on September 9, 2016. The global end date of the trial was January 29, 2019.
EudraCT Number 2016-001715-21.
Find the results here.
Trial Details
Completed in Belgium by UZ Leuven, this Phase II trial (EudraCT: 2016-001715-21) explored intravenous ketamine for treatment-resistant depression and bipolar disorder I and II. The randomised, double-blind, placebo-controlled trial involved 120 adults (18-64 years and ≥65 years) and aimed to replicate ketamine's efficacy, identify responders, and explore relapse markers. The primary endpoint was depressive symptom relief, with secondary endpoints including biomarkers and psychophysiology of stress. Authorized on July 27, 2016, with a favourable ethics committee opinion on September 9, 2016, the trial concluded globally on January 29, 2019.NCT Number 2016-001715-21