What side effects are associated with this type of intervention?

Common treatments for Schizoaffective Disorder, such as antipsychotic medications and mood stabilizers, have several known side effects. Antipsychotics can cause weight gain, sedation, extrapyramidal symptoms (e.g., tremors, rigidity), and metabolic changes like increased blood sugar and cholesterol levels. Mood stabilizers, including lithium and valproate, may lead to gastrointestinal distress, weight gain, tremors, and potential kidney or liver issues. Monitoring these side effects is essential, particularly with mobile app tracking of sociability, activity, and sleep, as changes in these areas can signal worsening symptoms or adverse effects.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of Schizoaffective Disorder, including paliperidone (Invega), which is specifically approved for this condition. Other antipsychotics like risperidone, quetiapine, and clozapine are also commonly used, although not specifically approved for Schizoaffective Disorder. These medications help manage symptoms such as hallucinations, delusions, and mood swings. The Mobile App trial focuses on passive mobile sensing to monitor sociability, activity, and sleep, which can be crucial for early intervention and management of symptoms in patients with serious mental illnesses, including Schizoaffective Disorder.

What other types of research exist?

Promising novel alternatives for schizoaffective disorder patients in 2024 include: 1) Digital platforms that provide real-time intervention and support, 2) Advanced telehealth services offering personalized treatment plans and regular virtual check-ins, and 3) Virtual Reality (VR) therapy for immersive and interactive treatment experiences.

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Smartphone App for Serious Mental Illness

N/A

Waitlist Available

Led By Alexander Stehle Young, MD MSHS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Under age 18

Has a conservator/legally authorized representative

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a mobile app for Veterans with serious mental illness. The app tracks movement, sleep, and social interactions using smartphone data. It aims to detect early signs of worsening mental health and alert users and their healthcare providers for timely intervention.

Who is the study for?

This trial is for adult Veterans at the Greater Los Angeles Veterans Healthcare Center diagnosed with serious mental illnesses like schizophrenia, schizoaffective disorder, or bipolar disorder. Participants must have had a risk of symptom exacerbation in the past year and own a smartphone with a data plan.

What is being tested?

The study tests an app that uses mobile phone data to monitor sociability, activity, and sleep as indicators of mental health status. It aims to detect early signs of relapse in patients with serious mental illnesses for timely intervention.

What are the potential side effects?

Since this trial involves using a mobile application for self-tracking without any medication or invasive procedures involved, there are no direct physical side effects expected from participating.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have a legal guardian or representative.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of passive self-tracking of mental health change

Estimates of activities

Estimates of sleep

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: mobile applicationExperimental Treatment1 Intervention

Participants use a mobile application on their smartphone

0 / 2Eligibility criteria met

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

The most common treatments for Schizoaffective Disorder include antipsychotics and mood stabilizers. Antipsychotics work by blocking dopamine receptors, particularly D2 receptors, to reduce psychotic symptoms like hallucinations and delusions. Mood stabilizers, such as lithium or valproate, help balance mood swings by modulating neurotransmitter activity and stabilizing neuronal excitability. These treatments are essential for managing both the psychotic and mood symptoms of Schizoaffective Disorder, leading to more comprehensive care. Mobile apps that passively monitor sociability, activity, and sleep can provide real-time data to clinicians, enabling timely treatment adjustments and potentially improving adherence and outcomes.

The response of subgroups of patients with schizophrenia to different antipsychotic drugs: a systematic review and meta-analysis.Symptom Remission and Brain Cortical Networks at First Clinical Presentation of Psychosis: The OPTiMiSE Study.