A Study of the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression

ConditionDepression
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression

Eligibility criteria

Qualifiers

Age range from 18 to 65 years old (including boundary values), both male and female;

Single or recurrent episodes that meet the diagnostic criteria for depression in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition);For patients with a single episode, the duration of this depressive episode must be ≥90 days.

Screening and baseline periods, the total score of the Montgomery Asperger Depression Rating Scale (MADRS) was ≥ 26 points;

Screening and baseline periods, with a Clinical Global Impression Scale Disease Severity (CGI-S) score of ≥ 4 points;

Disqualifiers

Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) ;

Those who have used at least two antidepressants in sufficient dosage and duration (treated according to the maximum dosage in the instructions for at least 4 weeks) in a single or current episode in the past but still have no effect;

The patients of depression secondary to other mental or physical illnesses;

Patients of depression with accompanying psychiatric symptoms;

Trial design

Treatments tested in this trial

  • Placebo group
  • JS1-1-01 low-dose group
  • JS1-1-01 high-dose group

Treatment groups

180 Participants
are divided into 3 treatment groups