iTEST for Psychotic Disorders

(iTEST Trial)

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Diego

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests iTEST, a mobile-based program designed to help people with schizophrenia or schizoaffective disorder improve their self-assessment skills and apply them to daily life. The goal is to reduce disability by enhancing their ability to judge their own abilities accurately.

Do I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, you need to have stable co-treatments, meaning no hospitalizations or changes in medication class for 2 months before joining the trial.

What data supports the idea that iTEST for Psychotic Disorders is an effective treatment?

The available research shows that Integrated Psychological Therapy (IPT), which is similar to iTEST, is more effective for people with non-treatment resistant schizophrenia compared to those with treatment-resistant schizophrenia. Patients with non-treatment resistant schizophrenia showed significant improvements in verbal memory, symptoms, and quality of life. These improvements were maintained over time. This suggests that iTEST could be effective, especially for those who are not resistant to treatment. ^{1 2 3 4 5}

What safety data is available for the iTEST treatment for psychotic disorders?

The provided research does not specifically mention iTEST or provide direct safety data for it. However, it discusses the safety of neuroleptics and antipsychotics in general, highlighting that atypical neuroleptics, such as clozapine, can cause severe adverse drug reactions (ADRs) in a small percentage of patients. The research also compares the safety of different antipsychotics like olanzapine and risperidone, suggesting that olanzapine may have some safety advantages. Additionally, the safety of antipsychotics in children and adolescents is explored, indicating the need for further research. Overall, while specific data on iTEST is not available, the general safety profile of antipsychotics is discussed. ^{6 7 8 9 10}

Is the treatment iTEST a promising treatment for psychotic disorders?

The information provided does not directly mention iTEST or its effectiveness as a treatment for psychotic disorders. Therefore, we cannot determine if iTEST is promising based on the given articles. ^{3 11 12 13 14}

Research Team

Eligibility Criteria

This trial is for adults aged 18 to 65 with schizophrenia or schizoaffective disorder, who can make informed decisions and have a contact person involved in their care. They should be able to read at a 6th-grade level and have stable treatments with no recent hospitalizations or medication changes. Participants must not be fully employed or financially independent due to their condition.

Inclusion Criteria

I understand and agree to participate in the study willingly.

I am between 18 and 65 years old.

≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device)

Exclusion Criteria

Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item >5)

DSM-5 alcohol or substance dependence in past 3 months based on interview

I need constant medical care that prevents me from attending outpatient therapy.

Treatment Details

Interventions

• iTEST (Behavioral Intervention)

Trial Overview The iTEST intervention uses mobile devices to help people with psychotic disorders improve how accurately they judge their own abilities and task performance. The goal is to enhance daily functioning by training introspective accuracy through the use of these devices.

Participant Groups

Group I: iTEST Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

The University of Texas at Dallas

Collaborator

Trials

71

Recruited

108,000+

Dr. Richard Benson

The University of Texas at Dallas

Chief Executive Officer since 2016

PhD in Molecular and Cell Biology from the University of Texas at Dallas

Dr. Patrizia Cavazzoni

The University of Texas at Dallas

Chief Medical Officer

MD from Harvard Medical School

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Findings from Research

Integrated Psychological Therapy (IPT) was found to be more effective for individuals with nontreatment resistant schizophrenia (NTRS) compared to those with treatment-resistant schizophrenia (TRS), based on a study involving 48 outpatients over a 10-week therapy period.

While IPT showed some improvements in TRS patients that were maintained at follow-up, the overall effectiveness of IPT was significantly higher in NTRS patients, indicating that different approaches may be needed for varying types of schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Psychological Therapy and Treatment-Resistant Schizophrenia: Initial Findings. Rakitzi, S., Georgila, P.[2020]

A new set of patient-reported outcome measures was developed for adolescents and adults with psychotic disorders, focusing on four key domains: symptoms, recovery, functioning, and treatment, based on input from over 100 stakeholders.

The final outcome set includes nine measures that can be completed in about 35 minutes, is free for users, available in multiple languages, and aims to enhance clinical decision-making and program evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an International Standard Set of Patient-Reported Outcome Measures for Psychotic Disorders. McKenzie, E., Matkin, L., Sousa Fialho, L., et al.[2022]

In a study involving 40 participants, including 25 with first-episode psychosis (FEP), group cognitive behavioral therapy (CBT) led to significant reductions in positive, depressive, and anxiety symptoms, as well as improved quality of life for both FEP and stable psychosis patients.

Notably, only the FEP group showed improvement in negative symptoms, suggesting that early intervention with CBT may be particularly beneficial for addressing these challenging symptoms in psychotic illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy as a treatment for negative symptoms in first-episode psychosis. Gaynor, K., Dooley, B., Lawlor, E., et al.[2018]

In a study of 80 individuals with schizophrenia, patients prioritized the treatment of affective and neuropsychological symptoms over positive symptoms, highlighting the need for a more holistic approach to treatment.

Patients found therapies like Talk, Psychoanalytic, and Art Therapy, as well as Metacognitive Training, to be the most helpful, suggesting that clinicians should align treatment plans with patient preferences to improve outcomes and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The customer is always right? Subjective target symptoms and treatment preferences in patients with psychosis. Moritz, S., Berna, F., Jaeger, S., et al.[2018]

Psychotherapy is effective for individuals with psychotic disorders, helping to reduce symptoms and improve overall quality of life, as supported by international guidelines.

Cognitive-behavioral therapy, family interventions, and psychoeducation are particularly beneficial, but successful treatment relies on a strong therapeutic relationship and coordination with other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychotherapy of psychotic disorders]. Lamster, F., Jäger, M.[2018]

In a study monitoring 86,439 patients treated with neuroleptics from 1993 to 2000, severe adverse drug reactions (ADRs) occurred in 1.1% of patients, with atypical neuroleptics causing more severe ADRs than typical ones, primarily due to clozapine-related issues.

When excluding clozapine, typical and atypical neuroleptics showed similar rates of severe ADRs, but their profiles differed, highlighting the importance of considering real-life ADR data for better treatment decisions in psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe adverse drug reactions in psychiatric inpatients treated with neuroleptics. Bender, S., Grohmann, R., Engel, RR., et al.[2007]

Pisa syndrome, a rare side effect of neuroleptic medications, was documented in 20 episodes among 17 patients in a study of 45,000 psychiatric patients, indicating its low frequency but potential risk in certain populations.

Risk factors for developing Pisa syndrome include previous treatment with classical neuroleptics, combined pharmacologic treatment, being female, older age, and having an organic brain disorder, suggesting that these patients require careful monitoring when prescribed neuroleptic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pisa syndrome (pleurothotonus): report of a multicenter drug safety surveillance project. Stübner, S., Padberg, F., Grohmann, R., et al.[2004]

Olanzapine demonstrated statistically significant improvements in both efficacy and safety compared to risperidone in treating schizophrenia, based on a meta-analysis of randomized, double-blind studies.

The analysis showed that olanzapine was associated with fewer anticholinergic side effects and lower dropout rates, indicating it may enhance patient quality of life and treatment adherence over both short (≤12 weeks) and longer-term (>12 weeks) periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of olanzapine versus risperidone for the treatment of schizophrenia: a meta-analysis of randomised clinical trials. Mudge, MA., Davey, PJ., Coleman, DK., et al.[2014]

A total of 45,201 adverse drug reactions (ADRs) were reported in children and adolescents treated with antipsychotics, with the most common being extrapyramidal syndrome (14.7%), breast disorders or changes in blood prolactin levels (4.7%), and cardiac arrhythmias (4.6%).

Differences in ADR reporting frequencies were noted between age groups and types of reporters, indicating that younger children (ages 1-5) reported fewer cases of hyperglycemia/new-onset diabetes compared to older adolescents (ages 12-17), which can help in tailoring monitoring and information about potential ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reported Adverse Drug Reactions in Children and Adolescents Treated with Antipsychotics. Minjon, L., van den Ban, E., de Jong, E., et al.[2020]

In a systematic review of 15 short-term trials involving 2208 children and adolescents, clozapine, molindone, olanzapine, and risperidone were found to be the most effective antipsychotics for reducing psychosis symptoms, with clozapine showing the highest effect size.

Long-term treatment evidence was limited, with only lurasidone demonstrating effectiveness, while clozapine and haloperidol were associated with significantly higher dropout rates due to adverse events, highlighting the need for more comprehensive trials in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy and Tolerability of Antipsychotics for Juvenile Psychotic Disorders: A Systematic Review and Network Meta-Analysis. Yee, CS., Bahji, A., Lolich, M., et al.[2022]

In a study of 3074 patients diagnosed with acute and transient psychotic disorders (ATPD), 46.25% developed persistent psychotic disorders within 8 years, highlighting a significant long-term risk associated with ATPD.

The cumulative risk of developing schizophrenia-spectrum disorders was particularly high, at 36.14% after 8 years, suggesting that early detection and preventive treatments could be crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term outcomes of acute and transient psychotic disorders: The missed opportunity of preventive interventions. Rutigliano, G., Merlino, S., Minichino, A., et al.[2021]

In a study of 73 first-hospitalized patients with acute and transient psychotic disorders, 42% did not experience any relapses over a follow-up period of three to seven years, indicating a favorable long-term outcome for many individuals.

However, 12% of patients experienced relapses that led to severe social impairment, suggesting that these cases may represent an early indication of a chronic condition rather than a transient disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Course and outcome of first-admitted patients with acute and transient psychotic disorders (ICD-10:F23). Focus on relapses and social adjustment. Jäger M D, M., Hintermayr, M., Bottlender, R., et al.[2009]

In a 2-year study of 68 patients with first-episode acute and transient psychotic disorders (ATPD), 55.9% showed diagnostic stability by the end of the follow-up, indicating a significant portion of patients may have consistent diagnoses over time.

Key predictors of diagnostic stability included the presence of motility disturbances, and the absence of hallucinations and schizophrenic features, suggesting that these factors could help identify patients whose ATPD diagnosis is likely to remain stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prognostic role of catatonia, hallucinations, and symptoms of schizophrenia in acute and transient psychosis. López-Díaz, Á., Fernández-González, JL., Lara, I., et al.[2020]

The incidence of acute and transient psychotic disorders (ATPDs) was found to be 6.7 per 100,000 person-years, with no significant gender differences, indicating a relatively common occurrence in the population.

Among ATPD subtypes, polymorphic psychotic disorder was more prevalent in females, while those with schizophrenic symptoms were more common in younger males, suggesting distinct demographic patterns that may inform future diagnostic criteria revisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variations in incidence and age of onset of acute and transient psychotic disorders. Castagnini, A., Foldager, L.[2021]

References

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

Integrated Psychological Therapy and Treatment-Resistant Schizophrenia: Initial Findings. [2020]

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

Developing an International Standard Set of Patient-Reported Outcome Measures for Psychotic Disorders. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy as a treatment for negative symptoms in first-episode psychosis. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

The customer is always right? Subjective target symptoms and treatment preferences in patients with psychosis. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Psychotherapy of psychotic disorders]. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Severe adverse drug reactions in psychiatric inpatients treated with neuroleptics. [2007]

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

Pisa syndrome (pleurothotonus): report of a multicenter drug safety surveillance project. [2004]

8. England pubmed.ncbi.nlm.nih.gov

A comparison of olanzapine versus risperidone for the treatment of schizophrenia: a meta-analysis of randomised clinical trials. [2014]

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

Reported Adverse Drug Reactions in Children and Adolescents Treated with Antipsychotics. [2020]

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

Comparative Efficacy and Tolerability of Antipsychotics for Juvenile Psychotic Disorders: A Systematic Review and Network Meta-Analysis. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Long term outcomes of acute and transient psychotic disorders: The missed opportunity of preventive interventions. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Course and outcome of first-admitted patients with acute and transient psychotic disorders (ICD-10:F23). Focus on relapses and social adjustment. [2009]

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

The prognostic role of catatonia, hallucinations, and symptoms of schizophrenia in acute and transient psychosis. [2020]

14. Germany pubmed.ncbi.nlm.nih.gov

Variations in incidence and age of onset of acute and transient psychotic disorders. [2021]