What is the mechanism of action of this treatment?

The most common treatments for schizophrenia primarily involve antipsychotic medications that target dopamine D2 receptors to reduce psychotic symptoms such as hallucinations and delusions. Some newer antipsychotics also affect serotonin receptors, which can help alleviate negative symptoms and cognitive deficits. These mechanisms are crucial for schizophrenia patients as they help manage the core symptoms of the disorder, improve overall functioning, and enhance quality of life. Understanding these mechanisms allows for better-targeted treatments and the development of new therapies, such as those being explored in trials like CT-156.

What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly second-generation antipsychotics, have a range of side effects. Clozapine, while effective, can cause significant side effects such as agranulocytosis, weight gain, and metabolic syndrome, requiring careful monitoring. Olanzapine is associated with weight gain and metabolic issues. Aripiprazole and risperidone generally have more favorable side effect profiles but can still cause extrapyramidal symptoms (EPS) like akathisia and dystonia. Brexpiprazole and cariprazine, newer atypical antipsychotics, share similar efficacy with potentially fewer EPS but can still lead to weight gain and metabolic disturbances. First-generation antipsychotics like haloperidol are more likely to cause EPS and other movement disorders.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation (typical) and second-generation (atypical) antipsychotics. First-generation antipsychotics like haloperidol and chlorpromazine have been used historically. Second-generation antipsychotics, which are more commonly used today, include clozapine, risperidone, olanzapine, quetiapine, and aripiprazole. Clozapine is noted for its efficacy in treatment-resistant schizophrenia, and aripiprazole is often used due to its favorable side effect profile. Augmentation strategies, such as combining clozapine with other antipsychotics like aripiprazole, have also been explored to enhance treatment outcomes.

What other types of research exist?

Promising novel alternatives to CT-156 for schizophrenia patients in 2024 include: 1) Long-acting injectable antipsychotics, which improve medication adherence and outcomes. 2) Pimavanserin, a serotonin-receptor modulator, which has shown efficacy in psychosis. 3) Quetiapine XR, which has been effective and well-tolerated in patients with suboptimal previous treatments. These options should be discussed with a healthcare provider to determine the best individualized treatment plan.

← Back to Search

Other

Abbreviated CT-156 for Schizophrenia

N/A

Waitlist Available

Research Sponsored by Click Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Is an adult at least 18 years of age at the time of informed consent

Meets diagnostic criteria for a primary diagnosis of schizophrenia as defined in the International Classification of Diseases, Eleventh Edition (ICD-11) or Diagnostic Statistical Manual, Fifth Edition (DSM-5) for at least 6 months prior to screening

Must not have

Is currently treated with more than two antipsychotic medications (including more than 2 dosage forms)

Meets ICD-11 or DSM-5 criteria for a current episode of depression, mania or hypomania

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 to week 4

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment app called CT-156 for people aged 18 or older with schizophrenia. The app aims to help manage their symptoms through various tools and information.

Who is the study for?

Adults over 18 with schizophrenia, fluent in English, living in the US, on stable antipsychotic medication for at least 3 months. They must be able to use a smartphone and an app for study communications. Excluded are those with acute symptoms preventing engagement with the app or on certain therapies like clozapine or multiple antipsychotics.

What is being tested?

The trial is testing CT-156-C-001's effects and practicality over four weeks in people with schizophrenia. Participants will be divided into two groups to compare outcomes using this new treatment approach alongside their regular medications.

What are the potential side effects?

Since specific side effects of CT-156-C-001 aren't listed, they may include typical reactions to psychiatric treatments such as dizziness, sleep issues, changes in appetite or mood swings. The exact profile will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with schizophrenia for at least 6 months.

Select...

I have been on the same antipsychotic medication for at least 3 months.

Exclusion Criteria

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

Select...

I am currently taking more than two antipsychotic medications.

Select...

I have been diagnosed with depression, mania, or hypomania.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 to week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 to week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to week 4 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Length of time in App

Number of days used

Number of tasks completed

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CT-156 + UXRExperimental Treatment1 Intervention

Study app investigational treatment for adult patients diagnosed with schizophrenia with up to five in-patient visits with three interviews for UXR (user experience research) arm.

Group II: CT-156Active Control1 Intervention

Study app investigational treatment for adult patients diagnosed with schizophrenia.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CT-156-C-001

2023

N/A

~60

0 / 5Eligibility 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 schizophrenia primarily involve antipsychotic medications that target dopamine D2 receptors to reduce psychotic symptoms such as hallucinations and delusions. Some newer antipsychotics also affect serotonin receptors, which can help alleviate negative symptoms and cognitive deficits. These mechanisms are crucial for schizophrenia patients as they help manage the core symptoms of the disorder, improve overall functioning, and enhance quality of life. Understanding these mechanisms allows for better-targeted treatments and the development of new therapies, such as those being explored in trials like CT-156.

Potential Utility of Biased GPCR Signaling for Treatment of Psychiatric Disorders.The past and future of novel, non-dopamine-2 receptor therapeutics for schizophrenia: A critical and comprehensive review.What's in a name? The evolution of the nomenclature of antipsychotic drugs.