Abbreviated CT-156 for Schizophrenia

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Click Therapeutics, Inc.

Must be taking: Antipsychotics

Must not be taking: Clozapine

Disqualifiers: Substance use disorder, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, CT-156, is effective and easy to use for individuals with schizophrenia. Participants will either use CT-156 alone or in combination with additional user experience research activities. The trial targets adults in the U.S. who have been diagnosed with schizophrenia for at least six months, are on consistent antipsychotic medication, and are comfortable using a smartphone app. The study seeks to understand how people with schizophrenia manage their condition with these new treatment options. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially improve future treatment options for schizophrenia.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current antipsychotic medications. In fact, you need to be on the same antipsychotic medication for at least 3 months before starting the trial, although dose adjustments are allowed during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CT-156, a newer medication for schizophrenia, is under study. These medications typically have safety levels similar to their pill forms. However, some reports indicate possible risks, such as worsening symptoms of psychosis or depression.

Treatments like CT-156 are generally well-tolerated, but side effects can occur, as with many medications. Participants should discuss these potential risks with their healthcare provider when considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CT-156 for schizophrenia because it could offer a fresh approach to managing this complex condition. Unlike current treatments like antipsychotics, which mainly target dopamine receptors, CT-156 might work through a novel pathway, potentially offering benefits for patients who do not respond well to existing medications. Additionally, the combination arm, CT-156 + UXR, incorporates user experience research, aiming to enhance how patients interact with their treatment, which could lead to improved compliance and outcomes. This unique focus on user experience alongside the treatment itself sets it apart from traditional therapies.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research has shown that CT-156 may help treat schizophrenia by targeting specific symptoms. Like clozapine, a well-known schizophrenia medication, CT-156 is being tested for its effectiveness in improving symptoms. In earlier studies, patients using CT-155, a similar treatment, experienced a significant reduction in negative symptoms, with a 6.8-point improvement. These results suggest that CT-156 might also help reduce symptoms in people with schizophrenia. The current trial will evaluate the effectiveness of CT-156 alone and in combination with UXR to understand patient responses to these treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Shaheen Lakhan

Principal Investigator

Click Therapeutics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form

Lives in the United States

Has regular access to the internet via cellular data plan and/or wi-fi

Exclusion Criteria

Has previously participated in specific study numbers

I have been in therapy, like CBT or vocational training, in the last 6 months.

I do not have mental health conditions like schizophrenia or severe depression that would affect my participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Study App for schizophrenia treatment, with up to five in-patient visits and three interviews for the UXR arm

4 weeks

Up to 5 in-patient visits, 3 interviews

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CT-156

Trial Overview 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.

How Is the Trial Designed?

Group I: CT-156 + UXR Experimental Treatment 1 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-156 Active Control 1 Intervention

Study app investigational treatment for adult patients diagnosed with schizophrenia.

Who Is Running the Clinical Trial?

Click Therapeutics, Inc.

Lead Sponsor

Trials

17

Recruited

2,900+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

In a review of 157 patients with schizophrenia, 6.9% of those on aripiprazole, 12.2% on paliperidone palmitate, and 17.2% on risperidone-LAI discontinued treatment due to adverse events, indicating that while some patients experience side effects, the majority tolerate the medication well.

Most adverse events were of moderate severity, with only three patients requiring hospitalization, suggesting that while LAI-SGA therapy can lead to discontinuation in some cases, serious complications are relatively rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patients with schizophrenia who discontinued long-acting injectable antipsychotic therapy due to adverse events: A chart review. Kishi, T., Sakuma, K., Okuya, M., et al.[2022]

Second-generation antipsychotic long-acting injections (SGA-LAIs) like aripiprazole and olanzapine are associated with significant treatment-emergent adverse events (TEAEs), including psychotic symptoms, extrapyramidal symptoms, weight gain, and metabolic disturbances, indicating safety concerns in their use.

The review highlights that SGA-LAIs do not demonstrate safety advantages over first-generation antipsychotics or oral medications, suggesting that non-pharmacological interventions may be beneficial for patients with schizophrenia and bipolar disorder who struggle with medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety concerns associated with second-generation antipsychotic long-acting injection treatment. A systematic update. Gentile, S.[2019]

Recent antipsychotic medications, including third-generation antipsychotics (TGA), show a good safety profile with lower metabolic side effects compared to older second-generation antipsychotics, based on a comprehensive review of multiple databases up to March 2020.

TGAs are particularly effective in targeting negative symptoms of mental disorders and improving cognitive functions, suggesting they may offer additional benefits beyond traditional antipsychotic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Up-to-date expert opinion on the safety of recently developed antipsychotics. Orsolini, L., De Berardis, D., Volpe, U.[2021]

Second-generation antipsychotic long-acting injections (SGA-LAIs) generally have safety profiles similar to their oral counterparts, but they also present new safety concerns, such as the risk of postinjection syndrome and worsening psychosis, particularly with olanzapine-LAI.

The review highlighted serious risks associated with risperidone-LAI and paliperidone palmitate, including worsening psychotic symptoms and a concerning link to increased suicide rates, emphasizing the need for further research to clarify these safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects associated with second-generation antipsychotic long-acting injection treatment: a comprehensive systematic review. Gentile, S.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06136936

NCT06136936 | A Study to Evaluate the Overall Effects of ... An exploratory, double-arm, 4-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12541272/

Protocol for the Phase 3 CONVOKE Randomized Controlled ... CONVOKE is the largest-to-date and most robust clinical trial evaluating the effectiveness and safety of a DTx in schizophrenia. The study ...

3. withpower.com withpower.com/trial/phase-schizophrenia-8-2023-102c8

Abbreviated CT-156 for Schizophrenia · Info for Participants What data supports the effectiveness of the drug CT-156 for treating schizophrenia? The research on clozapine, a similar drug, shows that it is effective ...

4. clicktherapeutics.com clicktherapeutics.com/news/boehringer-and-click-therapeutics-present-pivotal-data-for-investigational-prescription-digital-therapeutic-ct-155-showing-a-statistically-significant-reduction-in-negative-symptoms-of-schizophrenia

Stay up to date with news and updates Treatment with CT-155 demonstrated a Cohen's D effect size of -0.36 (p value= 0.0003) reflective of a 6.8-point improvement of negative symptoms ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06486948

NCT06486948 | An Exploratory, Double-arm, 8-week Study ... An exploratory, double-arm, 8-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.

6. pharmaphorum.com pharmaphorum.com/news/boehringer-click-dtx-schizophrenia-clears-pivotal-trial

Boehringer, Click DTx for schizophrenia clears pivotal trial Boehringer Ingelheim and Click Therapeutics have revealed the data behind their pivotal trial of a digital therapeutic for schizophrenia.