NCT03833206Toborzás még nem indult1/2. fázis

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: Part I Dose Escalation

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 20.

Rövid összefoglaló (regiszter, angolul)

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

Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
Tervezett résztvevők: 12
2027. jan. 15. és az elsődleges befejezés (2028. febr. 28.) között
1 helyszín, 1 országban
Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

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).
Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine).
Currently being treated with tamoxifen.

Have a documented history of an intellectual disability.
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.
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.

Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study.
** 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.

Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by:
- 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
- A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months.

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

Életkor a regiszterben: 21 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
Cedars-Sinai Health System	Los Angeles	Egyesült Államok	Ismeretlen állapot

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