Phase 2
Completed N=72
A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT02395978 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 Compared to Placebo for Part II. — -13.19; -9.21; -9.2; -13.4 score on a scale — p=0.393
Summary
The purpose of this study is to evaluate the safety and efficacy in patients with major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 Compared to Placebo for Part II. |
-13.19; -9.21; -9.2; -13.4; -10.4; -8.6 | 0.393 |
| SECONDARY Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2, 4 and 7 Part II. |
-7.4; -6.4; -5.5; -10.8; -7.6; -8.7 | — |
| SECONDARY Change of Hamilton Depression Rating Scale (HAM-D-17) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II. |
-7.9; -6.5; -4.3; -9.7; -7.5; -8.2 | — |
| SECONDARY Change of Hamilton Anxiety Rating Scale (HAM-A) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II. |
-5.4; -4.3; -2.9; -7.2; -5.5; -6.2 | — |
| SECONDARY Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II |
-3.6; -3.1; -1.7; -4.5; -5.6; -4.0 | — |
| SECONDARY Change of Clinical Global Impression Scale - Severity (CGI-S) From Baseline to Week 2, 4, 6 and 7 for Part II. |
-0.6; -0.7; -0.3; -1.1; -0.9; -0.9 | — |
| SECONDARY Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II. |
2; 4; 2; 9; 3; 4 | — |
| SECONDARY Number of Subjects With Suicidal Ideations Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II. |
1; 1; 4; 2; 1; 4 | — |
| SECONDARY Number of Subjects With Suicidal Behaviors Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Clinical Global Impression Scale -Improvement (CGI-I) From Baseline to Week 2, 4, 6 and 7 for Part II. |
3.0; 3.1; 3.4; 2.8; 3.1; 2.9 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatients aged 20-65 years
- Subjects must be able to understand and willing to sign informed consent
- 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
- 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).
- 17-item HAM-D (Hamilton Rating Scale for Depression) total score ≧20 and CGI (Clinical Global Impression) total score ≧4
Exclusion Criteria
- 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.
- Use of any treatment for MDD in the last 2 weeks before visit 1 (4 weeks for fluoxetine).
- 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.
- 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.
- Have a history of any seizure disorder.
- Any clinically significant abnormal vital sign, ECG, laboratory values as determined by the investigator which might interfere with the study.
- 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
- Have a high suicidal risk as measured by MINI.
- 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.
- Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
Data sourced from ClinicalTrials.gov (NCT02395978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.