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Trial record 65 of 1892 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder

A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT02395978
Recruitment Status : Recruiting
First Posted : March 24, 2015
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
BioLite, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy in patients with major depressive disorder.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: PDC-1421 Capsule Drug: placebo Phase 2

Detailed Description:

The screening phase is intended for diagnosing and assessing the patient for possible inclusion in the study and for providing an adequate washout period. The following study will be conducted in two parts. Part I is an open-label study, multiple center and dose escalation evaluation in twelve patients. Six subjects each will be evaluated for safety and efficacy assessments at 1 or 2 capsules TID dose for 28 days, sequentially. Each of them will be assessed twice in the first week after administration of PDC-1421 Capsules and once a week in the following treatment.

Part II is a randomized, double-blind, placebo-controlled, parallel-group study. 60 subjects will be randomly assigned on a 1:1:1 basis to one of the three arms (1 PDC-1421 Capsule plus 1 placebo TID, 2 PDC-1421 Capsules TID, 2 placebo TID) for 6 weeks and evaluated the safety and efficacy every two weeks during the treatment period.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder
Actual Study Start Date : March 2015
Actual Primary Completion Date : June 10, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2 PDC-1421 Capsule
2 PDC-1421 Capsule TID, p.o. after meal for 28 days
Drug: PDC-1421 Capsule
Experimental: 1 PDC-1421 Capsule plus 1 placebo
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 28 days
Drug: PDC-1421 Capsule
Drug: placebo
Placebo Comparator: 2 placebo
2 placebo TID, p.o. after meal for 28 days
Drug: placebo



Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]
    The primary endpoint is the change of Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to Week 6 compared to placebo.


Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 and 7 weeks ]
    MADRS total score-change from baseline to Visit 2 and 6 (Week 2 and 7).

  2. Hamilton Depression Rating Scale (HAM-D-17) [ Time Frame: 2, 4, 6 and 7 weeks ]
    Change from baseline to Visit 3, 4, 5 and 6 (Week 2, 4, 6 and 7)

  3. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 2, 4, 6 and 7 weeks ]
    Change from baseline to Visit 3, 4, 5 and 6 (Week 2, 4, 6 and 7)

  4. Depression and Somatic Symptoms Scale (DSSS) [ Time Frame: 2, 4, 6 and 7 weeks ]
    Change from baseline to Visit 3, 4, 5 and 6 (Week 2, 4, 6 and 7)

  5. Clinical Global Impression Scale (CGI) [ Time Frame: 2, 4, 6 and 7 weeks ]
    Change from baseline to Visit 3, 4, 5 and 6 (Week 2, 4, 6 and 7)

  6. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 2, 4, 6 and 7 weeks ]
    Percentage of partial responders (defined as a participant with a 25-50% decrease from baseline in total score) and responders (defined as a participant with ≧50% decrease from baseline in total score) in MADRS by week 2, 4, 6 and 7 weeks

  7. Safety Assessments and Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 2, 4, 6 and 7 weeks ]
    Evaluate Safety Assessments and Columbia-Suicide Severity Rating Scale (C-SSRS) from screening stage to week 2, 4, and 5.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients aged 20-65 years
  2. Subjects must be able to understand and willing to sign informed consent
  3. Female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study
  4. Met criteria for MDD without psychotic features as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision® (DSM-IV-TR) and confirmed by use of the Mini International Neuropsychiatric Interview (MINI).
  5. 17-item HAM-D (Hamilton Rating Scale for Depression) total score ≧20 and CGI (Clinical Global Impression) total score ≧4

Exclusion Criteria:

  1. Have a current or previous major psychiatric disorders which be defined to be per the DSM-IV-TR, including obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episode, schizophrenia, major Axis II disorders which might compromise the study, and major depression with psychotic symptoms, mental retardation.
  2. Use of any treatment for MDD in the last 2 weeks before visit 1 (4 weeks for fluoxetine).
  3. Use of psychoactive drugs within the last 2 weeks before visit 1 other than that subjects had insomnia who need the treatment as determined by the Investigator.
  4. Subjects who were non-responsive to two or more courses of antidepressant medications given an adequate dosage for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year.
  5. Have a history of any seizure disorder.
  6. Any clinically significant abnormal vital sign, ECG, laboratory values as determined by the investigator which might interfere with the study.
  7. Any organic disorder caused u medical related depression which cannot be under well-controlled such as clinically significant in neurological, gastrointestinal, renal, hepatic, cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders
  8. Have a high suicidal risk as measured by MINI.
  9. Have a history of substance abuse within the past 6 months or a positive urine drug screen for any substance of abuse at visit 1.
  10. Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395978


Contacts
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Contact: Frank Liu, M.D. 886-2-87518701 liu3763@bioliteinc.com
Contact: Richard King, Ph.D. +13142582428 richard.king@ambrivis.com

Locations
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United States, California
Stanford Depression Research Clinic Recruiting
San Francisco, California, United States, 94305
Contact: Charles DeBattista, M.D.         
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Cheng-Ta Li, M.D.,Ph.D         
Tri-Service General Hospital, Neihu Main Facility Recruiting
Taipei, Taiwan
Contact: Wei-Chung Mao, M.D.         
Wan Fang Hospital Recruiting
Taipei, Taiwan
Contact: Mong-Liang Lu, M.D.         
Linkou Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan
Principal Investigator: Chia- Yih Liu, M.D.         
Sponsors and Collaborators
BioLite, Inc.
Investigators
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Principal Investigator: Cheng-Ta Li, M.D. Department of Psychosomatic Medicine, Taipei Veterans General Hospital

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Responsible Party: BioLite, Inc.
ClinicalTrials.gov Identifier: NCT02395978     History of Changes
Other Study ID Numbers: Phase II BLI-1005-002
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms