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Hypidone Hydrochloride in Major Depressive Disorder
NCT03404466Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2018
- Primary completion
- Jul 2018
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- hypidone
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 2, randomised, open-label trial of hypidone in major depressive disorder (MDD) (2 arms), sponsored by Zhejiang Huahai Pharmaceutical Co., Ltd. Primary endpoint: Montgomery-Asberg Depression Rating Scale at 6 weeks. Started Feb 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
10 mg Group
Hypidone Hydrochloride 10 mg BID
20 mg Group
Hypidone Hydrochloride 20 mg BID
03
Who it enrols
Adult outpatients with current Major Depressive Disorder (MADRS >= 26) and no high suicide risk or other significant mental/medical disorders.
04
Endpoints
Primary
Montgomery-Asberg Depression Rating Scale
Secondary
Hamilton Depression Scale 17 items
Hamilton Anxiety Rating Scale
Clinical Global Impression of Severity Scale
Clinical Global Impression of Improvement Scale
Columbia-Suicide Severity Rating Scale
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