NCT03887624

Investigate the Clinical Responses of Ethosuximide in Patients With Treatment-Resistant Depression.

A Randomized, Parallel-group，Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of Ethosuximide in Chinese Patients With Treatment-Resistant Depression.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy and safety of ethosuximide in the treatment of refractory depressive disorder in adults. Half of participants will receive ethosuximide and escitalopram in combination, while the other half will receive a placebo and escitalopram.

Detailed description

Ethosuximide is a inhibitor of low-voltage-sensitive T-type calcium channels(T-VSCCs). It has higher selectivity to T-VSCCs and can enter cerebrospinal fluid through the blood-brain barrier, inhibit T-VSCCs on the lateral habenular nucleus neurons, and then inhibit the cluster discharge of neurons, resulting in a rapid antidepressant effect.

Conditions

• Depressive Disorder, Treatment-Resistant

Interventions

Type	Name	Description
DRUG	Ethosuximide	2 times/day, take it orally after breakfast/dinner; take 500mg in the morning and 500mg in the evening on day1, 500mg in the morning and 750mg in the evening on day2, 750mg in the morning and 750mg in the evening on day3, 750mg in the morning and 1000mg in the evening on day4, 1000mg in the morning and 1000mg in the evening on day5, maintain this dose until the end of treatment for 2 weeks.
DRUG	Placebo	2 times/day, take it orally after breakfast/dinner; take 500mg in the morning and 500mg in the evening on day1, 500mg in the morning and 750mg in the evening on day2, 750mg in the morning and 750mg in the evening on day3, 750mg in the morning and 1000mg in the evening on day4, 1000mg in the morning and 1000mg in the evening on day5, maintain this dose until the end of treatment for 2 weeks.
DRUG	Escitalopram	1 time/day, 20mg/day, take it orally after breakfast, take it for 4 weeks without interruption.

Timeline

• Start date: 2019-05-21
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2019-03-25
• Last updated: 2025-06-18

Locations

1 site across 1 country: China