ALTO-300 in Depression (ALTO-300-004)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05157945 |
Recruitment Status :
Completed
First Posted : December 15, 2021
Last Update Posted : April 26, 2024
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Sponsor:
Alto Neuroscience
Information provided by (Responsible Party):
Alto Neuroscience
Tracking Information | |||||
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First Submitted Date ICMJE | December 2, 2021 | ||||
First Posted Date ICMJE | December 15, 2021 | ||||
Last Update Posted Date | April 26, 2024 | ||||
Actual Study Start Date ICMJE | February 3, 2022 | ||||
Actual Primary Completion Date | April 26, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | ALTO-300 in Depression (ALTO-300-004) | ||||
Official Title ICMJE | AN OPEN-LABEL STUDY OF ALTO-300 IN ADULTS WITH MAJOR DEPRESSIVE DISORDER | ||||
Brief Summary | The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Major Depressive Disorder | ||||
Intervention ICMJE | Drug: ALTO-300 PO Tablet
One tablet daily
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Study Arms ICMJE | Experimental: ALTO-300
ALTO-300 tablet PO; daily dosing 8 weeks
Intervention: Drug: ALTO-300 PO Tablet
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
148 | ||||
Original Estimated Enrollment ICMJE |
200 | ||||
Actual Study Completion Date ICMJE | May 5, 2023 | ||||
Actual Primary Completion Date | April 26, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 74 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05157945 | ||||
Other Study ID Numbers ICMJE | ALTO-300-004 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Alto Neuroscience | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Alto Neuroscience | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Alto Neuroscience | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |