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

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.