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

53 Participants Needed

Trial Summary

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.

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 for patients with treatment-resistant schizophrenia, with 30% of patients responding positively compared to only 4% with another drug, chlorpromazine. ^{1 2 3 4 5}

What safety data exists for CT-156 (a second-generation antipsychotic) in humans?

Second-generation antipsychotic long-acting injections (SGA-LAIs) like CT-156 have been associated with side effects such as weight gain, psychotic symptoms, and metabolic disturbances. Some formulations, like olanzapine pamoate, can cause post-injection delirium/sedation syndrome (PDSS), which involves heavy sedation or delirium after injection. Overall, these medications have safety profiles similar to their oral versions, but certain risks like worsening of psychosis and depression have been noted. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Shaheen Lakhan

Principal Investigator

Click Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clozapine for the treatment-resistant schizophrenic. A double-blind comparison with chlorpromazine. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Translating research into practice: the Schizophrenia Patient Outcomes Research Team (PORT) treatment recommendations. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical Guidance on the Identification and Management of Treatment-Resistant Schizophrenia. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Real-World Assessment of Outcomes in Schizophrenia Patients According to Treatment Response. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

An algorithm for the treatment of schizophrenia in the correctional setting: the Forensic Algorithm Project. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Outcomes of patients with schizophrenia who discontinued long-acting injectable antipsychotic therapy due to adverse events: A chart review. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Up-to-date expert opinion on the safety of recently developed antipsychotics. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Post-injection delirium/sedation syndrome in patients treated with olanzapine pamoate: mechanism, incidence, and management. [2018]