Behaviors and Mental Disorders

All Conditions

Depressive Disorder

Depressive Disorder, Major

Depression

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Psychotropic Drugs

All Drugs and Chemicals

Psilocybin

Hallucinogens

psilocybin 25 mg sod

psilocybin 1 mg sod

Johan Lundberg

Helena Werin Sjögren, MD

Mikael Landén, MD PhD

Evana Lopez, MD

Carl-Johan Ekman, PhD

Evana Lopez

robert Bodén, MD PhD

Axel Nordenskjöld, MD PhD

axel Nordenskjöld, MD PhD

Johan Lundberg, MD PhD

The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is:

The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9)

≥10), \>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives).

Randomized Controlled Trial, active placebo, randomization ratio 2:1

Cancer Related Major Depression Treated With a Single Dose of Psilocybin

CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial

Montgomery Asberg Depression Rating Scale (MADRS) total score (0-60, smaller equals better)

Montgomery Asberg Depression Rating Scale self rating (MADRS-S) (0-54, smaller equals better)

Sheehan Disability Scale (SDS) (0-10, smaller equals better)

Clinical Global Impression (CGI), (1-7, smaller equals better)

Euroquol 5 Dimension scale (EQ5D-5L), 0-1, higher equals better

Assessing Quality of Life 6 dimensions (AQOL-6D) (0-99, smaller equals better)

General Anxiety Disorder 7 (GAD-7) (0-21, lower equals better)

Hospital Anxiety and Depression Scale (HADS) (0-42, smaller equals better)

Euroqol 5 Dimension scale (EQ5D-5L), 0-1, higher equals better

Uppsala University Hospital

Region Örebro County

Vastra Gotaland Region

Karolinska Institutet

Section for Affective Disorders; Northern Stockholm Psychiatry

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, Large-Cell, Anaplastic

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Anaplastic Large Cell Lymphoma

Sun Xiao-Fei

Zhen Zi-Jun

Sun Xiaofei

With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Studies in Germany and the United States have shown that pathological types of systemic anaplastic large cell lymphoma (ALCL) in children and adolescents, minimal disseminated disease (MDD) in peripheral blood or bone marrow and minimal residual disease (MRD) are significantly associated with prognosis, suggesting that these factors need to be combined in risk stratification of ALCL patients. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. We adjusted the original NHL-BFM-90/95 regimen, mainly in the aspects of clinical staging, efficacy evaluation, risk stratification and treatment regimen，etc.

Research purpose:

1. To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma.
2. To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival.
3. To explore the feasibility of risk stratification combined with adverse pathological types, dangerous organ invasion and MDD.
4. To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment.

A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL

A Prospective Multicenters Clinical Cohort Study of the Efficacy and Safety of Stratified Risk Factors for Treatment of Chinese Children With Systemic ALK-positive Anaplastic Large Cell Lymphoma

EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies

OS is defined as time from start of treatment/randomization up to death of any

RFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease, or relapse.

Complete response, partial remission, objective effect, stable disease or progressive disease

Rate of patients with acute toxicity defined as grade III/IV/V AE

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer Related Major Depression Treated With a Single Dose of Psilocybin	NCT06319378	MDD	psilocybin 25 m... psilocybin 1 mg...	20 Years - 80 Years	Section for Affective Disorders; Northern Stockholm Psychiatry
A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL	NCT03971305	MRD MDD Lymphoma, Nonho... Anaplastic Lymp... Pediatric Cance...		1 Year - 18 Years	Sun Yat-sen University
A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL	NCT03971305	MRD MDD Lymphoma, Nonho... Anaplastic Lymp... Pediatric Cance...		1 Year - 18 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for mdd

Every month we try and update this database with for mdd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mdd

Every month we try and update this database with for mdd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mdd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.