A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients
A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in
 cancer patients with depression.
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.