This study wants to assess antidepressant how well it works differences between ALTO-100 and dummy treatment (placebo) during the neither you nor the study doctors know who gets the real treatment period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and how well it works will be assessed in a subsequent open label treatment period.
Official registry: https://clinicaltrials.gov/study/NCT06656416 · Alto Neuroscience · enrollment listed as 200
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are ALTO-100, or Placebo. The registry lists allocation as randomized. This study wants to assess antidepressant how well it works differences between ALTO-100 and dummy treatment (placebo) during the neither you nor the study doctors know who gets the real treatment period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics.
They plan to enroll about 200 people at 68 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode
Interventions: ALTO-100, Placebo
Primary outcome (registry wording): To assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Alto Neuroscience
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 10 sites outside the US on the same record
Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG).
NCT00018057 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies.
NCT02543983 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary