Clinical trials: Psychosis; Episode
First Episode Psychosis
Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs
Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC).
- Trial name
- NCT04005378
- Testing
- CSC Step-down intervention, Usual Care
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Psychosis, Mental Disorder
Assessment and Evolution of Narrative Identity and Its Relationship to Subjective Multidimensional Well-being and Multidimensional Recovery in First Episode Psychosis
First episode psychosis (FEP) constitutes an important subgroup within psychotic disorders, as the acute impact of a disorder at the time of diagnosis may differ from its long-term impact over the following decades.
- Trial name
- PEPID (NCT07330843)
- Testing
- Narrative identity task
- Where
- France
- Volunteers
- 96 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Family Members
Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis
Investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis.
- Trial name
- NCT04188366
- Testing
- FAMES, Treatment-as-Usual
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Washington State University
Bipolar I Disorder, Schizoaffective Disorder
Open Label Extension Study of NCT06221852
This is a 12-week open-label extension study for participants completing study NCT06221852.
- Conditions
- Bipolar I Disorder, Schizoaffective Disorder, Psychosis
- Trial name
- NCT06558201
- Testing
- Ketogenic diet
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mclean Hospital
Schizophrenia, First-Episode Psychosis
Using mHealth to Optimize Pharmacotherapy Regimens
This project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team…
- Trial name
- NCT04248517
- Testing
- mHealth Intervention
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- New York State Psychiatric Institute
Bipolar Disorder, Affective Disorders, Psychotic
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.
- Conditions
- Bipolar Disorder, Affective Disorders, Psychotic, Mood Disorders, Mental Disorders
- Trial name
- NCT00035802
- Testing
- Topiramate
- Volunteers
- 13 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Schizophrenia
Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia
This Study is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/day and 6 mg/day in Patients with Acute Psychotic…
- Trial name
- NCT05168007
- Testing
- WID-RGC20(Cariprazine) 3mg/day, WID-RGC20(Cariprazine) 6mg/day
- Where
- South Korea
- Volunteers
- 342 people
- Sponsor
- Whanin Pharmaceutical Company
First Episode Psychosis
Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes
The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.
- Trial name
- ESPRITO (NCT04004364)
- Testing
- Coordinated Specialty Care (CSC)
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Northwell Health
Schizophrenia, Major Depressive Disorder (MDD)
A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive…
- Conditions
- Schizophrenia, Major Depressive Disorder (MDD), Bipolar Disorder
- Trial name
- NCT07549581
- Testing
- SEP-380135
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Inflammatory Bowel Diseases, Depressive Episode
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the impacts on quality-of-life outcomes and use of healthcare services in people aged 5 - 25 years…
- Conditions
- Inflammatory Bowel Diseases, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorder
- Trial name
- NCT05206734
- Testing
- No specific intervention
- Where
- United Kingdom
- Volunteers
- 19,469 people, healthy volunteers welcome
- Sponsor
- Momentum Data
Insomnia, Psychosis
Implementation of Digital CBT for Insomnia in First Episode Psychosis
This study uses mixed methods to investigate the implementation of digital cognitive behavioural therapy for insomnia (Sleepio) in a first episode of psychosis service (FEP).
- Conditions
- Insomnia, Psychosis, First Episode Psychosis
- Trial name
- NCT05050201
- Testing
- Sleepio
- Where
- 2 sites in United Kingdom
- Volunteers
- 22 people
- Sponsor
- NHS Greater Glasgow and Clyde
Psychotic Disorders
Effects of a Peer-facilitated, Recovery-focused Self-illness Management Program for First-episode Psychosis
Psychosis is a major disabling and disruptive mental illness characterized by a wide variety of disturbances in cognition and emotions, resulting in poor psychosocial functioning and frequent relapses.
- Trial name
- Peer-RESIM (NCT06487195)
- Testing
- Peer-facilitated, Recovery-based Self-illness-management programme, Psycho-education group, Treatment-as-usual only
- Where
- Hong Kong
- Volunteers
- 198 people
- Sponsor
- Chinese University of Hong Kong
Psychotic Episode
Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis
The First-Episode Psychosis (FPE) is a severe disorder that can include delusions, cognitive disorders and suicidal behavior. In the majority of cases (more than 80%) it evolves into schizophrenia.
- Trial name
- PRESTO (NCT05813457)
- Testing
- PRESTO Early Identification Program
- Where
- 6 sites in France
- Volunteers
- 416 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Psychosis
Intervention Module AGES
The AGES-CM consortium aims to study the interaction between the polymorphisms of the candidate genes related with neurodevelopment, neurotransmission, brain progressive changes, cognitive functioning and stressful life events…
- Trial name
- AGES-CM (NCT02101372)
- Testing
- treatment as usual, Psychoeducation group treatment
- Where
- Spain
- Volunteers
- 55 people
- Sponsor
- Celso Arango
Early Psychosis
Decision-making and Decision Support Among Emerging Adults With First Episode Psychosis
The purpose of this study is to evaluate the impact of an antipsychotic medication decision aid and interpersonal and cognitive factors, such as attachment style and motivation, on emerging adults' ability to engage in shared…
- Trial name
- NCT04373590
- Testing
- Decision aid
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Temple University
First Episode Psychosis (FEP), Caregiver Burden
Psychoeducation Program for Family Caregivers Coordinated by an APRN
The aim of this study is to assess the impact of implementing a specific family program coordinated by APRNs, covering the 5 levels of the family care pyramid through a consultation, an individual psychoeducation program and a…
- Conditions
- First Episode Psychosis (FEP), Caregiver Burden, Nurse Practitioners, IMPACT OF A NEW PSYCHOEDUCATION PROGRAM COORDINATED BY AN ADVANCED PRACTICE NURSE ON THE BURDEN OF FAMILY CAREGIVERS OF PATIENTS WITH A FIRST PSYCHOTIC EPISODE
- Trial name
- APIPEP (NCT07041463)
- Testing
- Psychoeducation program coordinated by an APRN, Usual Care
- Where
- 5 sites in France
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Hôpital le Vinatier
Schizophrenia
A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse
The study aims to address the following questions: 1. Do subgroups defined by early medication choices, relapse, and medication taken over 20 years differ in clinical, cognitive, and functional outcomes? 2.
- Trial name
- NCT07616999
- Where
- China
- Volunteers
- 178 people
- Sponsor
- The University of Hong Kong
Psychosis
A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis
In the first year of treatment after a FE of SCZ, 75% to 90% of patients achieve remission from psychotic symptoms. However, approximately 40% of FE patients are non-adherent to medication regimes and more than 60% have…
- Trial name
- PSTEP (NCT00722163)
- Testing
- Cognitive Behavioural Therapy, befriending
- Where
- Canada
- Volunteers
- 330 people
- Sponsor
- Ontario Mental Health Foundation
Schizophrenia; Psychosis, First Episode Psychosis
Repetitive Transcranial Magnetic Stimulation in Early Psychosis and The Functional Connectivity Biotypes
The present study plans to explore different cortical targets of repetitive transcranial magnetic stimulation (rTMS) for populations at the early phase of psychosis, including those at clinical high risk of psychosis and in the…
- Conditions
- Schizophrenia; Psychosis, First Episode Psychosis, Clinical High Risk
- Trial name
- NCT04853485
- Testing
- repetitive transcranial magnetic stimulation (rTMS)
- Where
- 6 sites in China
- Volunteers
- 300 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Schizophrenia, Metabolic Syndrome
Optimizing and Individualizing the Pharmacological Treatment of First-episode Schizophrenic Patients
The study is performed in 20 different hospitals from 19 cities in China. Three sub-projects are included. About sub-project 1, we build a clinical database system and a biological sample bank for data and samples management…
- Trial name
- NCT03451734
- Testing
- antipsychotic medications, adjunctive group, metformin and lifestyle intervention
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Central South University