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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:
NCT01524497
First received: January 13, 2012
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Trazodone
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Lee's Pharmaceutical Limited:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale-17 score [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Changes in HAMA-14 score [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    Change from baseline in HAMA-14 score at Visit 6/final visit

  • CGI-Severity of illness and CGI-Global improvement [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit

  • Changes in evaluation of sleep quality and sexual dysfunction [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    change from baseline in evaluation of sleep quality and sexual dysfunction at Visit 6/final visit

  • Rate changes of responders/patients [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 382
Study Start Date: November 2011
Study Completion Date: November 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trazodone Drug: Trazodone
75mg tablet/150 mg tablet
Placebo Comparator: Placebo Drug: Placebo
Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Serious suicide attempts (≥ 3 on item 3 'Suicide' of HAMD);
  2. Depressive episode, with psychotic symptoms;
  3. Refractory depression;
  4. Depressive episode secondary to other mental or physical disorders;
  5. Bipolar disorder;
  6. Significant reduction in body weight and malnutrition induced by major depression;
  7. Serious or unstable heart, hepatic, renal, endocrine and hematologic disease or malignant tumors;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524497

Locations
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
Study Director: Benjamin LI, Ph.D. Lee's Pharmaceutical company
  More Information

No publications provided

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01524497     History of Changes
Other Study ID Numbers: Trazodone_1
Study First Received: January 13, 2012
Last Updated: October 14, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Lee's Pharmaceutical Limited:
losing interest and feelings of guilt
poor concentration
loss of appetite
suicide

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Trazodone
Anti-Anxiety Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014