ALTO-100 in Bipolar Disorder With Depression (BD-D)
Recruiting
Phase 2
Interventional Study
Bipolar Disorder I or II With a Major Depressive Episode
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Alto Neuroscience · Industry
Who this trial is looking for
This trial is looking for adults who have bipolar disorder along with a current major depressive episode and are already taking a mood stabilizer. It’s important that they haven't changed their medication in the last two weeks and are not pregnant or breastfeeding. They can't have other serious health issues, be currently using certain medications, or have a history of severe substance use problems.
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About This Trial
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind 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 efficacy will be assessed in a su…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Have a diagnosis of BD-I or BD-II as well as BD-D
* At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA and/or taking an approved atypical antipsychotic medication (olanzapine, quetiap…
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