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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02395978
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
BioLite, Inc.

Tracking Information
First Submitted Date  ICMJE September 17, 2014
First Posted Date  ICMJE March 24, 2015
Last Update Posted Date November 25, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date June 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 4 weeks ]
The primary endpoint is the change of Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to Week 4 compared to placebo.
Change History Complete list of historical versions of study NCT02395978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • 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).
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 and 5 weeks ]
    MADRS total score-change from baseline to Visit 3 and 5 (Week 2 and 5).
  • Hamilton Depression Rating Scale (HAM-D-17) [ Time Frame: 2, 4 and 5 weeks ]
    Change from baseline to Visit 3, 4 and 5 (Week 2, 4 and 5)
  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 2, 4 and 5 weeks ]
    Change from baseline to Visit 3, 4 and 5 (Week 2, 4 and 5)
  • Depression and Somatic Symptoms Scale (DSSS) [ Time Frame: 2, 4 and 5 weeks ]
    Change from baseline to Visit 3, 4 and 5 (Week 2, 4 and 5)
  • Clinical Global Impression Scale (CGI) [ Time Frame: 2, 4 and 5 weeks ]
    Change from baseline to Visit 3, 4 and 5 (Week 2, 4 and 5)
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 2, 4 and 5 weeks ]
    Percentage of partial responders (defined as a participant with a 20-39% decrease from baseline in total score) and responders (defined as a participant with ≧40% decrease from baseline in total score) in MADRS by week 2, 4 and 5.
  • Safety Assessments and Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 2, 4, 5 weeks ]
    Evaluate Safety Assessments and Columbia-Suicide Severity Rating Scale (C-SSRS) from screening stage to week 2, 4, and 5.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder
Official Title  ICMJE A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder
Brief Summary The purpose of this study is to evaluate the safety and efficacy in patients with major depressive disorder.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: PDC-1421 Capsule
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: 2 PDC-1421 Capsule
    2 PDC-1421 Capsule TID, p.o. after meal for 28 days
    Intervention: 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
    Interventions:
    • Drug: PDC-1421 Capsule
    • Drug: placebo
  • Placebo Comparator: 2 placebo
    2 placebo TID, p.o. after meal for 28 days
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2015)
100
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date June 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02395978
Other Study ID Numbers  ICMJE Phase II BLI-1005-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioLite, Inc.
Study Sponsor  ICMJE BioLite, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheng-Ta Li, M.D. Department of Psychosomatic Medicine, Taipei Veterans General Hospital
PRS Account BioLite, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP