Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Alto Neuroscience
Must be taking:Antipsychotics
Must not be taking: Mood stabilizers, Clozapine, Benzodiazepines
Disqualifiers: Unstable condition, Bipolar, Dementia, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in change in electroencephalogram (EEG) cognitive processing markers and measures of cognition.
Additional goals are to assess pharmacokinetic (PK), safety, and tolerability of the recently developed ALTO-101T transdermal delivery system (TDS) formulation in a patient population.
Will I have to stop taking my current medications?
The trial requires that you stay on a stable dose of 1-2 antipsychotic medications for at least 8 weeks before joining. However, you cannot participate if you are using mood stabilizers, clozapine, or daily benzodiazepines.
Eligibility Criteria
This trial is for individuals with schizophrenia, particularly those experiencing cognitive impairment. Participants should meet specific health criteria and not have conditions that could interfere with the study or pose a risk.Inclusion Criteria
I have been diagnosed with schizophrenia for over a year.
Exclusion Criteria
I am currently experiencing a major depressive episode.
I have been diagnosed with schizoaffective, bipolar disorder, dementia, or intellectual disability.
I have a health condition that is not stable.
I have not been hospitalized for psychiatric reasons in the last 6 months.
I am currently taking medication for mood stabilization, clozapine, or daily benzodiazepine.
Participant Groups
The study tests ALTO-101 delivered through the skin (transdermal) against a placebo to see if it improves brain function markers and cognition in schizophrenia patients. It's also checking how the body processes the drug and its safety.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALTO-101Experimental Treatment2 Interventions
10 days administration of ALTO-101T transdermal delivery system (18-27 mg/day as a total of 6 patches/day)
Group II: PlaceboPlacebo Group2 Interventions
10 days administration of placebo transdermal delivery system (with a total of 6 placebo patches/day)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Site 5060Hollywood, FL
Site 5056Chicago, IL
Site 5055Cedarhurst, NY
Site 5083Garden Grove, CA
More Trial Locations
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Who is running the clinical trial?
Alto NeuroscienceLead Sponsor
References
Olanzapine for patients with treatment-resistant schizophrenia: a naturalistic case-series outcome study. [2018]This prospective, consecutive case-series outcome investigation evaluates the effectiveness of olanzapine in 16 patients with treatment-resistant schizophrenia.
Healthcare resource use and costs reduction with aripiprazole once-monthly in schizophrenia: AMBITION, a real-world study. [2023]This study aims to compare the hospitalization rate in individuals with schizophrenia who started their treatment with aripiprazole once monthly (AOM400) or atypical oral antipsychotics (OA) in Spain.
The GiSAS study: rationale and design of a pragmatic randomized controlled trial on aripiprazole, olanzapine and haloperidol in the long-term treatment of schizophrenia. [2018]Given the controversy about the comparative efficacy of first- compared with second-generation antipsychotics in the treatment of schizophrenia, more large-scale evidence is needed to guide clinicians in their prescriptions. Most randomized controlled trials (RCTs) were conducted in centers of excellence on highly selected samples, poorly representative of real-world patients, and often suffered conflicts of interest as they were sponsored by drug companies. The primary aim of the present study is to compare the effectiveness of haloperidol, olanzapine and aripiprazole in a representative sample of schizophrenia patients. The GiSAS trial is an open-label, independent, pragmatic RCT in Italian community-based public psychiatric services. At least 260 patients meeting the DSM-IV criteria for schizophrenia will be randomly allocated to one of the study drugs and followed up for one year. A two-year observational phase will follow. The primary outcome for tolerability will be the onset of metabolic syndrome. The primary endpoint for effectiveness will be discontinuation of antipsychotic monotherapy. Secondary measures include global functioning, time to discontinuation due to side-effects, change of lipid profile, extrapyramidal symptoms and other adverse effects. In the last four years, the GiSAS study group has been working to implement this multicenter RCT. The trial mechanism is now fully functional and working. As of end of February 2011, 260 subjects were randomized by 54 study investigators in 33 out of 43 participating centers.
Early Improvement of Psychiatric Symptoms with Long-Acting Injectable Antipsychotic Predicts Subsequent Social Functional Remission in Patients with Schizophrenia. [2022]The aim of this study was to clarify whether early symptomatic improvement in response to a long-acting injectable antipsychotic (LAI) contributes to subsequent social functional remission in patients with schizophrenia using the previous clinical trial data (EudraCT registration number: 2011-004889-15). Associations between other factors and social functional remission were also explored.
Effects of aripiprazole once-monthly on symptoms of schizophrenia in patients switched from oral antipsychotics. [2017]To assess the effects of aripiprazole once-monthly 400 mg (AOM 400) on clinical symptoms and global improvement in schizophrenia after switching from an oral antipsychotic.