Clinical Trials List
Protocol NumberBLI-1005-002
NCT Number(ClinicalTrials.gov Identfier)NCT02395978
2014-11-15 - 2019-08-31
Phase II
Terminated4
ICD-10F33.9
Major depressive disorder, recurrent, unspecified
A phase II study of PDC-1421 Capsule to evaluate the safety and efficacy in patients with major depressive disorder (MDD)
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Trial Applicant
BioLite, Inc.
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Sponsor
BioLite
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- W. C. LIN Division of Psychiatry
- Ya-Mei Bai Division of Psychiatry
- T.P. SU Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 黃三原 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Chun-Hsin Chen Division of Psychiatry
- Winston-W Shen Division of Psychiatry
- Yi-Hang Chiu Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
major depressive disorder
Objectives
To assess the efficacy profile of PDC-1421 Capsule in
major depressive disorder with Montgomery-Å sberg
Depression Rating Scale (MADRS).
To evaluate the efficacy and safety profile of PDC-1421
Capsule in major depressive disorder with other rating
scales.
Test Drug
PDC-1421 Capsule
Active Ingredient
PDC-1421
Dosage Form
capsule
Dosage
380 mg/膠囊
Endpoints
Primary:
˙ Change in Montgomery-Å sberg Depression Rating
Scale (MADRS) total score from baseline to week 6
compared to placebo.
Secondary:
˙ Change in MADRS total score from baseline to week
2 and 7.
˙ Change in Hamilton Rating Scale for Depression
(HAM-D-17), Hamilton Rating Scale for Anxiety
(HAM-A), Depression and Somatic Symptoms Scale
(DSSS), Clinical Global Impression Scale (CGI) total
score from baseline to week 2, 4, 6 and 7.
˙ 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.
˙ Evaluate Safety Assessments and Columbia-Suicide
Severity Rating Scale (C-SSRS) from screening stage
to the last visit
˙ Difference in the mean changes of MADRS,
HAM-D-17, HAM-A, DSSS, CGI and C-SSRS from
the baseline to week 2, 4, 6 and 7 between the
PDC-1421 Capsule and placebo groups.
˙ Change in Montgomery-Å sberg Depression Rating
Scale (MADRS) total score from baseline to week 6
compared to placebo.
Secondary:
˙ Change in MADRS total score from baseline to week
2 and 7.
˙ Change in Hamilton Rating Scale for Depression
(HAM-D-17), Hamilton Rating Scale for Anxiety
(HAM-A), Depression and Somatic Symptoms Scale
(DSSS), Clinical Global Impression Scale (CGI) total
score from baseline to week 2, 4, 6 and 7.
˙ 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.
˙ Evaluate Safety Assessments and Columbia-Suicide
Severity Rating Scale (C-SSRS) from screening stage
to the last visit
˙ Difference in the mean changes of MADRS,
HAM-D-17, HAM-A, DSSS, CGI and C-SSRS from
the baseline to week 2, 4, 6 and 7 between the
PDC-1421 Capsule and placebo groups.
Inclution 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
(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 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 duration 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.
(2) Use of any treatment for MDD in 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 duration 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.
The Estimated Number of Participants
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Taiwan
100 participants
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Global
115 participants
