BridgeMD
New treatment option for Schizophrenia
Official title Study of ALTO-101 in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT06502964
What this study is testing
What is ALTO-101?
ALTO-101 is an investigational medicine, 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 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.
- 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's taking place
- 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
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.