Major Depressive Disorder
Conditions
Brief summary
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.
Interventions
DRUGPDC-1421 Capsule
PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
Sponsors
BioLite, Inc.
American BriVision Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria * 21 to 85 Years of age * Diagnosis of Stage I, II or III cancer * Histologically-proven malignancy * Receiving or within one year of having received cancer treatment with radiation and/or chemotherapy * Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms) * Duration of depressive symptoms ≥ 2 weeks by patient report. * No active/acute suicidality requiring immediate care or psychiatric hospitalization * Sufficient English language proficiency to complete all assessments without assistance * Able to swallow pills * No severe anemia, defined as hemoglobin \< 10 g/dL * No history of multiple adverse drug reactions or allergy to study drugs * Not pregnant * No history of head trauma * No history of epilepsy * No other concurrent antidepressant medications
Exclusion criteria
* Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus). * Have a documented history of an intellectual disability. * Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine). * Currently being treated with tamoxifen. * Subjects who were non-responsive to two or more courses of antidepressant medications given at 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, or laboratory values as determined by the investigator which might interfere with the study. * Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by: 1. A positive response to question 4 or 5, indicating endorsement of suicidal ideation with at least some intent to act in the past month; and/or 2. A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months. * Have a history of substance dependence/abuse\*\* within the past 6 months or a positive drug screen result during the screening period. * Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions. * \* An adequate dosage of the antidepressant medication is defined as the average of the usual dose (mg/day) recommended in American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition. E.g. the usual dose of Citalopram is 20-60 mg/day, the adequate dosage is 40 mg/day. * \*\* Tobacco is excluded here, and alcohol abuse is defined as average pure alcohol intake is more than 112 g (for male) or 56 g (for female) per week and/or with Alcohol withdrawal syndrome. Pure alcohol intake =% (Concentration or alcohol content) x c.c. (volume)x 0.79 (density of alcohol). Result of serum ethanol test should be equal to or lower than 10.0 mg/dL to be determined as eligible for the trial. If test result is between 10.1 to 29.9 mg/dL, only one re-test is allowed per subject to meet the criterion. Subject with test result equal to or higher than 30.0 mg/dL is to be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) | 5 weeks | Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1, 2, 3, 4, and 5 in patients taking 1 or 2 PDC-1421 capsules. The MADRS is a 10-item checklist including 1) depression \[apparent\]; 2) depression \[reported\]; 3) loss of interest; 4) suicidal ideation; 5) tension; 6) reduced appetite; 7) insomnia; 8) difficulty in activities; 9) concentration; and 10) pessimism. The MADRS is administered by a trained interviewer. Each item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 \[no sadness\] to 6 \[extremely despondent\]). The total score is used to define treatment response (≥50% reduction from baseline) and partial response (20-49% reduction from baseline). Remission is defined as a score of \< 10. The following are used as an interpretation of scores: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression |
Countries
United States
Contacts
CONTACTShirley Chiu, Ph.D.
CONTACTHsien-Ming Wu, MS
PRINCIPAL_INVESTIGATORscott A Irwin, MD/PhD
Cedars-Sinai Health System
Outcome results
None listed