a phase i/ii study of pdc-1421 for treating depression in cancer patients

Conditions: Major Depressive Disorder

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


Eligibility criteria:
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.