Schizophrenia study: ALTO-101
Official title Study of ALTO-101 in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT06502964
What this study is testing
What is ALTO-101?
This is an investigational patch being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the ALTO-101T patch changes brain waves and thinking skills in people with schizophrenia. It also looks at how the patch behaves in the body and how safe it is.
- Who it's for
- You may be able to join if you have schizophrenia and trouble with thinking.
- What's involved
- You will wear a patch on your skin that releases medicine. You will have brain wave tests and thinking tests. You will also have check‑ins to see how you feel.
- Time commitment
- The study lasts about 6 weeks. You will visit at the start, middle, and end to wear the patch and do tests.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 55
You may be able to join if
- Schizophrenia diagnosis for at least one year
- Cognitive impairment
- Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2
- Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening
- Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive)
You likely can't join if
- Evidence of unstable medical condition
- Acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months
- Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability
- Current episode of major depressive disorder (MDD)
- Use of mood stabilizer, clozapine, and/or daily benzodiazepine
- Current moderate or severe substance use disorder
See the full eligibility criteria
- Schizophrenia diagnosis for at least one year
- Cognitive impairment
- Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2
- Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening
- Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive)
- Willing to comply with all study assessments and procedures
- Evidence of unstable medical condition
- Acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months
- Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability
- Current episode of major depressive disorder (MDD)
- Use of mood stabilizer, clozapine, and/or daily benzodiazepine
- Current moderate or severe substance use disorder
The study team makes the final eligibility decision.
Where it is enrolling
- Garden Grove, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Walnut Creek, California, United States
- Hollywood, Florida, United States
- Tampa, Florida, United States
- Snellville, Georgia, United States
- Chicago, Illinois, United States
- Gaithersburg, Maryland, United States
- Belmont, Massachusetts, United States
- New York, New York, United States
- White Plains, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Garden Grove, California, United States; Los Angeles, California, United States; Orange, California, United States; Walnut Creek, California, United States; Hollywood, Florida, United States; Tampa, Florida, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.