Clinical trials: Early Psychosis, open to volunteers
Psychosis
Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis
Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset.
- Trial name
- PSYCARE (NCT05796401)
- Testing
- Cognitive training, Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC, Treatment as usual (TAU)
- Where
- 13 sites in France
- Volunteers
- 500 people
- Sponsor
- Centre Hospitalier St Anne
Clinical High Risk, Early Psychosis
Digital Strategies to Advance Help-Seeking Aim 1 and 2
This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis.
- Conditions
- Clinical High Risk, Early Psychosis, First Episode Psychosis
- Trial name
- NCT06774430
- Where
- United States
- Volunteers
- 25,000 people
- Sponsor
- Columbia University
First Episode Psychosis (FEP), Clinical High Risk for Psychosis (CHR)
Reducing the Duration of Untreated Psychosis in the United States: The Impact of Screening and Systematic Communication
The goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce…
- Trial name
- EaSIE (NCT05509998)
- Testing
- Screening Method (SM), Screening and Communication Method (SCM)
- Where
- United States
- Volunteers
- 912 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Schizophrenia, Psychotic Disorders
Dimensional and Developmental Profiles of Psychosis in Children and Adolescents
Five collaborating sites in France will study the broad spectrum of schizophrenia in children and adolescents. Patients will be studied with diagnostic interviews, developmental histories, dimensional clinical ratings…
- Trial name
- PSYDEV (NCT04370730)
- Testing
- clinical, neuroimaging and DNA assessments
- Where
- 6 sites in France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Psychosis, First Episode Psychosis
Stratification and Treatment in Early Psychosis Study - ENHANCE
The purpose of this study is: To investigate whether the response to antipsychotic treatment can be enhanced by adding cannabidiol (CBD) to the existing treatment, compared to placebo, in participants with a first episode of…
- Conditions
- Psychosis, First Episode Psychosis, Psychotic Disorders, Psychotic Episode
- Trial name
- STEP-ENHANCE (NCT06778564)
- Testing
- CBD 100 mg/mL Oral Solution
- Where
- 17 sites in Austria, Germany and 7 more
- Volunteers
- 250 people
- Sponsor
- University of Oxford
Psychosis, Alcohol Use Disorder
Piloting of an Intervention to Reduce Problematic Alcohol Use in Early Phase Psychosis Patients
A focus of research for youth and Emerging Adults with early phase psychosis (EPP) has been cannabis use. However, this focus has led to overlooking the possible negative influence of another legal recreational drug, alcohol.
- Trial name
- NCT05365347
- Testing
- Cognitive Enhancement Therapy (CET)
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Nova Scotia Health Authority
Clinical High Risk for Psychosis (CHR), Clinical High Risk for Psychosis
Stratification and Treatment in Early Psychosis Study - PROMOTE
The purpose of this trial is: To investigate whether cannabidiol (CBD), compared to placebo, can reduce the severity of attenuated psychotic symptoms in individuals at clinical high risk for psychosis.
- Conditions
- Clinical High Risk for Psychosis (CHR), Clinical High Risk for Psychosis, Clinical High Risk for Developing Psychosis
- Trial name
- STEP-PROMOTE (NCT07434973)
- Testing
- Cannabidiol (CBD)
- Where
- 19 sites in Austria, Canada and 8 more
- Volunteers
- 586 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Psychosis; Acute
Cerebellum-based Imaging Neural Markers for Antipsychotic Response
This study plans to collect 120 patients with first-episode psychosis. Participants will receive multimodal MRI scans (naturalistic fMRI, structural, diffusional) and comprehensive clinical assessments at baseline, and…
- Trial name
- CINEMA (NCT07483294)
- Testing
- risperidone, aripiprazole
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Northwell Health
Human Immunodeficiency Virus, Mental Disorder
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya.
- Trial name
- NCT06117163
- Testing
- Collaborative Care Model
- Where
- Kenya
- Volunteers
- 900 people
- Sponsor
- University of Colorado, Denver
Early Psychosis
Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis
This is an outpatient, single center, between-group, double blind, placebo controlled design. Approximately 120 adolescents and adult patients will be randomized to either have their treatment augmented with Cannabidiol Oral…
- Trial name
- NCT04411225
- Testing
- Cannabidiol oral solution
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- University of California, San Diego
First Episode Psychosis (FEP)
Self-administered COgnitive Personalized Training in Early Psychosis
The overall objective of SCOPe is to improve early intervention in psychosis by providing an innovative eHealth tool that will enable personalized cognitive training, adapted to the individual's cognitive abilities.
- Trial name
- SCOPe (NCT06634446)
- Testing
- a mobile application for cognitive training, video games
- Where
- France
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier St Anne
Treatment Resistant Psychosis, Psychosis
Stratification and Treatment in Early Psychosis Study -ASSIST
The purpose of this trial is: To investigate whether the response to clozapine treatment can be enhanced by adding cannabidiol (CBD), compared to placebo, in treatment resistant psychosis patients.
- Trial name
- STEP-ASSIST (NCT07326124)
- Testing
- CBD 100 mg/mL Oral Solution, Placeb
- Where
- 15 sites in Germany, Greece and 6 more
- Volunteers
- 250 people
- Sponsor
- University of Oxford
Psychosis, Schizophrenia
Enhanced Coordinated Specialty Care for Early Psychosis
The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis.
- Conditions
- Psychosis, Schizophrenia, Schizoaffective Disorder, Psychosis Nos/Other
- Trial name
- NCT06071858
- Testing
- Care Coordination, Individual Peer Support, Digital Outreach
- Where
- 5 sites in United States
- Volunteers
- 350 people
- Sponsor
- Mclean Hospital
Psychosis
Predicting Psychotic Relapse Using Speech-Based Early Detection
Psychotic disorders, including schizophrenia and affective psychosis, are severe mental health conditions marked by recurrent episodes that contribute to long-term disability.
- Trial name
- MOTS+ (NCT06978894)
- Where
- 3 sites in Canada
- Volunteers
- 250 people
- Sponsor
- Douglas Mental Health University Institute
Psychosis, Alcohol Use Disorder
Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis
Psychotic disorders impact 4.6 people per 1000 globally, with approximately 1.5 million Canadians affected. The age of onset for psychotic disorders often begin during the critical years of youth and early adulthood, resulting in…
- Conditions
- Psychosis, Alcohol Use Disorder, Cannabis Use Disorder
- Trial name
- NCT07056894
- Testing
- Action-Based Cognitive Remediation
- Where
- 2 sites in Canada
- Volunteers
- 50 people
- Sponsor
- Nova Scotia Health Authority
Prodromal Schizophrenia
Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. Whether treatment of an NMDA-enhancing agent can benefit the treatment of prodromal schizophrenia…
- Trial name
- NCT05052853
- Testing
- NMDAE
- Where
- Taiwan
- Volunteers
- 48 people
- Sponsor
- China Medical University Hospital
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Young people at clinical high risk for psychosis are more likely to experience suicide thoughts than the general population, but there are few suicide prevention programs designed specifically for them.
- Conditions
- Clinical High Risk for Psychosis (CHR), Suicidal Ideation, Psychosis, Suicidal Behavior
- Trial name
- NCT07756567
- Testing
- Suicide Prevention Intervention, Standard Care (in control arm)
- Where
- 2 sites in United States
- Volunteers
- 108 people
- Sponsor
- University of California, San Diego
Violence Risk, Early Psychosis
BRAVE Program to Improve Safety and Reduce Violence Risk in Early Psychosis
This study evaluates the feasibility and acceptability of BRAVE, a manualized cognitive behavioral therapy (CBT)-based intervention designed to address dynamic risk factors for violence among young adults with early psychosis.
- Trial name
- BRAVE (NCT07417904)
- Testing
- BRAVE (Behavioral Response Against Violence Engagement), Treatment As Usual (TAU)
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Howard University
Early Psychosis, Psychosis
State Representation in Early Psychosis 2
This observational study will examine behavioral and electroencephalography measures related to state representation in individuals with early psychosis and healthy control participants.
- Conditions
- Early Psychosis, Psychosis, Schizophrenia, Bipolar Disorder With Psychosis
- Trial name
- STEP2 (NCT07834203)
- Where
- 2 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Delusional Disorder, Brief Psychotic Disorder
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
FEEL-GOOD is a prospective multi-site single-blinded randomized controlled trial in young inpatients with acute early psychosis. Participants are randomized 1:1 to FEEL-GOOD plus treatment as usual (TAU) or TAU alone.
- Conditions
- Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, Schizophrenia / Schizoaffective Disorder
- Trial name
- FEEL-GOOD (NCT07645443)
- Testing
- FEEL GOOD, Treatment as Usual (TAU)
- Where
- 8 sites in Germany
- Volunteers
- 252 people
- Sponsor
- Stephanie Mehl