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

Phase 1

Not yet recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: PDC-1421 Capsule

• Registration Number: NCT03833206
• Lead Sponsor: BioLite, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Study Start: 2026-01-15
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
1 PDC-1421 Capsule	PDC-1421 Capsule	1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
2 PDC-1421 Capsules	PDC-1421 Capsule	2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cedars-Sinai Health System; 🇺🇸 Los Angeles, California, United States