Schizophrenia Clinical Trial
— STEP (P4)Official title:
State Representation in Early Psychosis - Project 4
The purpose of this study is to examine state representation in individuals aged 15-45 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. The investigators will complete a clinical trial examining two paradigms of cognitive training.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 45 Years |
Eligibility | Inclusion Criteria: - English proficiency, as determined by staff observation and participant self-report - Estimated IQ at or above 70, as estimated by the cognitive assessments Additional Inclusion Criteria for Early Psychosis Participants: - Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis; participants aged 36-45 must have onset of psychosis within the past 5 years - Achieved clinical stability, defined as outpatient status for at least one month prior to study participation Exclusion Criteria: - Unable or unwilling to provide informed consent - The participant is unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study - Participant is pregnant - Participant is illiterate - Cannot pass the CMRR Subject Safety Screen due to MRI contraindications - Presence of a major neurological disorder - Previous clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-Is - Meets criteria for substance or alcohol dependence within 3 months of enrollment - The presence of any major medical condition that, in the opinion of the PI/Co-Is, would impede participation in the study or would put the participant at additional risk by participating - Presence of severe alcohol or substance abuse Additional Exclusion Criteria for Early Psychosis Participants: - Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is - Meets criteria for clinical risk of suicidal behavior, as defined by: Clinician judgement - A suicide attempt within 6 months of enrollment - Active suicidal ideation at screening or baseline, as indicated by the C-SSRS - Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment, as indicated by the C-SSRS Additional Exclusion Criteria for Control Participants: - Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorder - Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Performance of DPX Task Variant | The DPX task variant consists of a series of pattern sequences. One pattern is designated the "A" cue, and another the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evokes a valid response, BX trials place demands on the fidelity (stability, memory) of the "B" cue state representation to overcome this tendency. | Baseline, Immediately after the intervention, 5 month follow up | |
Primary | Change in Performance of Bandit Task Variant | This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated. | Baseline, Immediately after the intervention, 5 month follow up | |
Primary | Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score. | The investigators will examine global cognition scores from the Test My Brain neurocognitive battery. Z scores range from -5 to 5, with higher score indicating increased cognitive functioning. | Baseline, Immediately after the intervention, 5 month follow up | |
Primary | Change in EEG Variables | Analysis will examine variables including phase synchrony, slope of the spectral power density (indexing E-I balance), and prefrontal/parietal theta as a measure of perceptual noise. | Baseline, Immediately after the intervention, 5 month follow up | |
Primary | Change in MRI Variables | MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale | This 29-item measure assesses symptoms in several domains such as anxiety, depression, sleep problems, somatic symptoms, and substance use. Scores range from 0 to 116, with a higher score indicating greater symptom severity. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in symptoms and functioning as indicated by the SANS/SAPS | The Scale for Assessment of Negative Symptoms (SANS, 25 items) and Scale for Assessment of Positive Symptoms (SAPS, 34 items) assess negative and positive symptoms of schizophrenia in a standardized interview. Scores on the SANS ranges from 0-125, and the SANS ranges from 0-170, with higher scores indicating increased symptom severity. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in symptoms and functioning as indicated by the BPRS | The Brief Psychiatric Rating Scale is a 24-item interview which assesses psychiatric symptoms. Scores on the BPRS rang from 24-168, with a higher score indicating increased symptom severity. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in symptoms and functioning as indicated by the SPQ-BR | Schizotypal Personality Questionnaire Brief Revised, a 32-item measure to assess a broad array of schizotypal symptoms and signs. The SPQ ranges from 32-160, with a higher score indicating greater schizotypy. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in symptoms and functioning as indicated by the SGI | The Sensory Gating Inventory Brief is a 10-item measure assesses an individual's subjective ability to modulate, filter, over-include, discriminate, attend to, and tolerate sensory stimuli. The SGI ranges from 10-60, with higher score indicating increased perceptual abnormalities. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in symptoms and functioning as indicated by the IDI | The Intersectional Discrimination Index is a 31-item measure assesses anticipated, day to day, and major discrimination experienced by the participant. Scores range from 0-136, with higher scores indicating greater discrimination experienced by the individual. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in symptoms and functioning as indicated by the WHODAS 2.0 Brief | The World Health Organization Disability Assessment Schedule is a 12-item self-administered scale measuring disability and functional impairment. The WHODAS ranges in score from 12-60, with a higher score indicating increased disability. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in symptoms and functioning as indicated by the GFS/GFR | The Global Functioning Social/Global Functioning Role scales provide a rating on a scale from 1-10 for social functioning and for role functioning, with higher scores indicating increased functioning. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in Test My Brain Neurocognitive Assessment performance: Digit Symbol Matching Z Score | This subdomain of the TMB battery assesses processing speed. Z scores range from -5 to 5, with higher score indicating increased functioning. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score | This subdomain of the TMB battery assesses verbal learning. Z scores range from -5 to 5, with higher score indicating increased functioning. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score | This subdomain of the TMB battery assesses reasoning skills and also provides an IQ estimate. Z scores range from -5 to 5, with higher score indicating increased functioning. | Baseline, Immediately after the intervention, 5 month follow up | |
Secondary | Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score | This subdomain of the TMB battery is a social cognition test that assesses the ability to recognize emotions (happiness, sadness, anger, and fear). Z scores range from -5 to 5, with higher score indicating increased functioning. | Baseline, Immediately after the intervention, 5 month follow up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |