What side effects are associated with this type of intervention?

Common treatments for schizophrenia include antipsychotic medications, cognitive behavioral therapy (CBT), and various psychosocial interventions. Antipsychotic medications, particularly second-generation antipsychotics like aripiprazole and risperidone, are preferred due to fewer extrapyramidal symptoms but can still cause side effects such as weight gain, metabolic syndrome, and sedation. CBT and psychosocial interventions, including metacognitive training and social skills training, generally have fewer physical side effects but require consistent participation and can be limited by accessibility and the need for trained facilitators. Musical Intervention (MI) and similar therapies focus on engagement and cognitive processes, potentially offering fewer adverse effects but requiring further study to confirm efficacy and safety.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation and second-generation antipsychotics. Second-generation antipsychotics, such as aripiprazole, risperidone, and clozapine, are preferred due to their relatively favorable side effect profiles and reduced risk of extrapyramidal symptoms compared to first-generation antipsychotics like haloperidol. These medications work by modulating neurotransmitter activity in the brain, particularly dopamine and serotonin receptors, to alleviate psychotic symptoms. While the Musical Intervention (MI) study explores non-pharmacological treatments, these FDA-approved drugs remain the cornerstone of schizophrenia management.

What other types of research exist?

Promising novel alternatives to Musical Intervention (MI) for schizophrenia patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive symptoms and may help with auditory hallucinations. 2) Cognitive Behavioral Therapy (CBT) tailored for psychosis, which helps patients reframe delusions and hallucinations. 3) Neurofeedback training, which aims to modulate specific brain wave patterns associated with auditory verbal hallucinations. 4) Sensory integration therapies, which address sensory dysfunctions that may contribute to symptoms. These alternatives offer diverse approaches targeting different aspects of schizophrenia.

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Behavioural Intervention

Music Therapy for Schizophrenia (SING_R33 Trial)

N/A

Recruiting

Led By Philip R Corlett, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and within one week of study completion (final mi session of 4)

Awards & highlights

SING_R33 Trial Summary

This trial investigates how music intervention can help people with voice-hearing in the context of a psychotic illness, with the ultimate goal of finding the most effective way to use this intervention.

Who is the study for?

This trial is for individuals who hear voices daily and have been diagnosed with a psychotic disorder as per the Diagnostic and Statistical Manual-V. They must exhibit moderate hallucinations, be able to give informed consent, interact well with the study team, and likely complete the study.Check my eligibility

What is being tested?

The SING trial tests how different forms of musical intervention affect people with schizophrenia. Participants are randomly assigned to create music, perform karaoke, listen to pop music or curate playlists. The impact on hallucinations, social learning, and language use is measured.See study design

What are the potential side effects?

Since this trial involves musical interventions rather than medications or invasive procedures, traditional side effects are not expected. However, participants may experience varying psychological responses based on their interaction with music.

SING_R33 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and within one week of study completion (final mi session of 4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and within one week of study completion (final mi session of 4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and within one week of study completion (final mi session of 4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Conditioned Hallucinations

Change in Language Use

Change in Social Belief Updating

SING_R33 Trial Design

1Treatment groups

Experimental Treatment

Group I: Musical InterventionExperimental Treatment1 Intervention

Participants will work together in a group with other voice hearers, making music with a trained facilitator for 4 weekly sessions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Musical Intervention

2020

N/A

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia include antipsychotic medications and psychosocial interventions. Antipsychotic medications work by modulating neurotransmitter systems, particularly dopamine and serotonin, to reduce symptoms like hallucinations and delusions. Psychosocial interventions, such as cognitive-behavioral therapy (CBT), social skills training, and family-based interventions, aim to improve cognitive and social functioning. The Musical Intervention (MI) being studied leverages the predictive processing framework, focusing on active participation and ownership in music creation to enhance cognitive processes and social interactions. This holistic approach is crucial for improving both symptom management and overall quality of life for schizophrenia patients.

Group therapy for schizophrenia: A meta-analysis.Relapse prevention in ambulant mental health care tailored to patients with schizophrenia or bipolar disorder.Treatment of early onset schizophrenia: recent trends, challenges and future considerations.

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Who is running the clinical trial?

Yale UniversityLead Sponsor

1,864 Previous Clinical Trials

2,742,065 Total Patients Enrolled

59 Trials studying Schizophrenia

3,819 Patients Enrolled for Schizophrenia

National Institute of Mental Health (NIMH)NIH

2,799 Previous Clinical Trials

2,660,964 Total Patients Enrolled

250 Trials studying Schizophrenia

89,261 Patients Enrolled for Schizophrenia

Philip R Corlett, PhDPrincipal InvestigatorYale University

2 Previous Clinical Trials

40 Total Patients Enrolled

2 Trials studying Schizophrenia

40 Patients Enrolled for Schizophrenia

Media Library

Musical Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05929352 — N/A

Schizophrenia Research Study Groups: Musical Intervention

Schizophrenia Clinical Trial 2023: Musical Intervention Highlights & Side Effects. Trial Name: NCT05929352 — N/A

Musical Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929352 — N/A

~52 spots leftby Jan 2025

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