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
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
Treatments tested in this trial
- PDC-1421 Capsule
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
BioLite, Inc.
Lead sponsor
American BriVision Corporation
Collaborator
Source ClinicalTrials.gov