Expired Study
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San Francisco, California 94305


Purpose:

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


Study summary:

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.


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.


Study is Available At:


Original ID:

Phase II BLI-1005-002


NCT ID:

NCT02395978


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

20 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

BioLite, Inc.


Oversight Authority:

  • United States: Food and Drug Administration
  • Taiwan : Food and Drug Administration
  • Taiwan: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:Cheng-Ta Li, M.D.
Principal Investigator
Department of Psychosomatic Medicine, Taipei Veterans General Hospital

Study Dates

Start Date:March 2015
Completion Date:September 30, 2019
Completion Type:Actual
Primary Completion Date:June 10, 2019
Primary Completion Type:Actual
Verification Date:November 2019
Last Changed Date:November 21, 2019
First Received Date:September 17, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Safety Assessments and Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame:2, 4, 6 and 7 weeks
Safety Issues:False
Description:Evaluate Safety Assessments and Columbia-Suicide Severity Rating Scale (C-SSRS) from screening stage to week 2, 4, and 5.
Outcome Type:Secondary Outcome
Measure:Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame:2, 4, 6 and 7 weeks
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Clinical Global Impression Scale (CGI)
Time Frame:2, 4, 6 and 7 weeks
Safety Issues:False
Description:Change from baseline to Visit 3, 4, 5 and 6 (Week 2, 4, 6 and 7)
Outcome Type:Secondary Outcome
Measure:Depression and Somatic Symptoms Scale (DSSS)
Time Frame:2, 4, 6 and 7 weeks
Safety Issues:False
Description:Change from baseline to Visit 3, 4, 5 and 6 (Week 2, 4, 6 and 7)
Outcome Type:Secondary Outcome
Measure:Hamilton Anxiety Rating Scale (HAM-A)
Time Frame:2, 4, 6 and 7 weeks
Safety Issues:False
Description:Change from baseline to Visit 3, 4, 5 and 6 (Week 2, 4, 6 and 7)
Outcome Type:Secondary Outcome
Measure:Hamilton Depression Rating Scale (HAM-D-17)
Time Frame:2, 4, 6 and 7 weeks
Safety Issues:False
Description:Change from baseline to Visit 3, 4, 5 and 6 (Week 2, 4, 6 and 7)
Outcome Type:Secondary Outcome
Measure:Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame:2 and 7 weeks
Safety Issues:False
Description:MADRS total score-change from baseline to Visit 2 and 6 (Week 2 and 7).
Outcome Type:Primary Outcome
Measure:Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame:6 weeks
Safety Issues:False
Description:The primary endpoint is the change of Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to Week 6 compared to placebo.

Study Interventions

Intervention Type:Drug
Name:PDC-1421 Capsule
Arm Name:1 PDC-1421 Capsule plus 1 placebo
Intervention Type:Drug
Name:placebo
Arm Name:1 PDC-1421 Capsule plus 1 placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2 placebo
Description:2 placebo TID, p.o. after meal for 28 days
Study Arm Type:Experimental
Arm Name:1 PDC-1421 Capsule plus 1 placebo
Description:1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 28 days
Study Arm Type:Experimental
Arm Name:2 PDC-1421 Capsule
Description:2 PDC-1421 Capsule TID, p.o. after meal for 28 days

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:BioLite, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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