A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients

ConditionMajor Depressive Disorder

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age21-85

SponsorBioLite, Inc.

About this trial

The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

PDC-1421 Capsule
Drug
PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.

Treatment groups

12 Participants

are divided into 2 treatment groups

Group A: 1 PDC-1421 CapsuleExperimental treatment 1 intervention

Group B: 2 PDC-1421 CapsulesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Montgomery-Åsberg Depression Rating Scale (MADRS)

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

Time frame

5 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioLite, Inc.

Lead sponsor

American BriVision Corporation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: