Trial intelligence / Profile preview

Orcinoside in Major Depressive Disorder

NCT02191384Phase 2

Key facts

Status: Completed
Start: Jul 2014
Primary completion: Mar 2016
Countries: 1
Sponsor: Shanghai Mental Health Center
Modality: Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules

Drugs: orcinoside
Conditions: major depressive disorder (MDD)

Overview

Phase 2, randomised, double-blind trial of orcinoside in major depressive disorder (MDD) (7 arms), sponsored by Shanghai Mental Health Center. Primary endpoints: Change of total score from baseline in Montgomery-Åsberg Depression Rating Scale at 6 weeks and Change of total score from baseline in Hamilton Depression Rating Scale at 6 weeks. Started Jul 2014; status: completed.

Design

7 arms

Study design: RandomizedDouble-blind

Orcinoside 25mg
Orcinoside 25mg per day
Orcinoside 50mg
Orcinoside 50mg per day
Orcinoside 100mg
Orcinoside 100mg per day
Orcinoside 200mg
Orcinoside 200mg per day
Orcinoside 400mg
Orcinoside 400mg per day
Orcinoside 600mg
Orcinoside 600mg per day

1 more in the full profile.

Who it enrols

Adult outpatients aged 18-65 with a primary diagnosis of Major Depressive Disorder (single or recurrent, without psychotic symptoms) and a HAMD-17 score between 18 and 24. Patients with significant suicide risk, other psychiatric diagnoses, substance abuse, or unstable medical conditions are excluded.

Endpoints

Primary

Change of total score from baseline in Montgomery-Åsberg Depression Rating Scale6 weeks
Change of total score from baseline in Hamilton Depression Rating Scale6 weeks

Secondary

Response Rate6 weeks
Remission Rate6 weeks
Decreasing rate from baseline in MADRS6 weeks
Decreasing rate from baseline in HAMD scale6 weeks
Change from baseline in Hamilton Anxiety Rating Scale6 weeks
Clinical Global Impression (CGI-S, CGI-I)6 weeks
Sleep Visual Analogue Scale6 weeks

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