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NCT Number: NCT01524497

A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for treatment of depression in Chinese population.

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Key information

Conditions

Depression Anorexia Behavior Behavioral Symptoms Pathological Conditions, Signs and Symptoms Self-Injurious Behavior Signs and Symptoms Signs and Symptoms, Digestive Suicide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65, males and females, outpatients or inpatients;
  • Single episode or recurrent depression according to DSM-IV (Version 4) criteria;
  • Scores > 18 on 17-item HAM-D at screening and baseline visits with a decrease not exceeding 20% between the two visits;
  • Symptoms of depression for at least 1 month;
  • Patients or their dependents/guardians providing signed informed consent forms.

Exclusion criteria

  • Serious suicide attempts (≥ 3 on item 3 'Suicide' of HAMD);
  • Depressive episode, with psychotic symptoms;
  • Refractory depression;
  • Depressive episode secondary to other mental or physical disorders;
  • Bipolar disorder;
  • Significant reduction in body weight and malnutrition induced by major depression;
  • Serious or unstable heart, hepatic, renal, endocrine and hematologic disease or malignant tumors;

Treatment and study plan

Trazodone

Drug

75mg tablet/150 mg tablet

Placebo

Drug

Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)

Primary outcomes

  1. Change in Hamilton Depression Rating Scale-17 score

    Time frame: six weeks

    17-item Hamilton Depression Rating scale were evaluated at the basemline and six weeks after treatment, the changes were recorded and used as primary outcome measurement.

Secondary outcomes

  1. Changes in HAMA-14 score

    Time frame: Six weeks

    Change from baseline in HAMA-14 score at Visit 6/final visit

  2. CGI-Severity of illness and CGI-Global improvement

    Time frame: Six weeks

    CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit

  3. Changes in evaluation of sleep quality and sexual dysfunction

    Time frame: Six weeks

    change from baseline in evaluation of sleep quality and sexual dysfunction at Visit 6/final visit

  4. Rate changes of responders/patients

    Time frame: Six weeks

    rate of responders, defined as patients with a 50% improvement from baseline in the HAMD score at Visit6/final visit;or rate of patients with remission, defined as patients with HAMD score ≤7 at Visit 6/final visit.

Sponsors and collaborators

Lead sponsor

Lee's Pharmaceutical Limited

Industry

Registry information

Official study title

A Clinical Study on Efficacy And Safety of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression A Multicenter, Randomized, Double-Blind, Parallel Controlled Study

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 2, 2012
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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