- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05118750
ALTO-300 in Depression
May 19, 2023 updated by: Alto Neuroscience
An Open-label Study of ALTO-300 in Adults With Major Depressive Disorder
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jillian Autea
- Phone Number: 650-397-5693
- Email: jillianautea@altoneuroscience.com
Study Contact Backup
- Name: Lesley Parker
- Email: lparker@altoneuroscience.com
Study Locations
-
-
California
-
Culver City, California, United States, 90230
- Site 153
-
Sacramento, California, United States, 95757
- Site 103
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Santee, California, United States, 92071
- Site 158
-
-
Florida
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Clermont, Florida, United States, 34711
- Site 159
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Okeechobee, Florida, United States, 34972
- Site 161
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Indiana
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Noblesville, Indiana, United States, 46060
- Site 137
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-
Missouri
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Saint Charles, Missouri, United States, 63304
- Site 166
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-
New York
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New York, New York, United States, 10023
- Site 132
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Texas
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Dallas, Texas, United States, 75235
- Site 102
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DeSoto, Texas, United States, 75115
- Site 165
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Fort Worth, Texas, United States, 76104
- Site 147
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- have a diagnosis of MDD based on the Structured Clinical Interview for DSM-5 (SCID) for depression
- have moderate to severe depression on DSM-5 depression criteria items, as assessed by a score of ≥10 on the Patient Health Questionnaire-9 (PHQ-9) at each of Visits 1, 2, and 3
- at baseline (Visit 2) are taking a stable dose of a single SSRI, serotonin-norepinephrine reuptake inhibitor (SNRI), or bupropion and have been on that medication for ≥6 weeks at an adequate dosage defined by the Antidepressant Treatment Response Questionnaire (ATRQ), and with no modification to dosage for ≥2 weeks.
- have either: had a continuous period of euthymia of at least 2 months in the past 26 months, regardless of the number of failed antidepressants OR not had a period of euthymia of at least 2 months in the past 26 months but within the past 24 months have not failed >3 antidepressants at an adequate dosage and duration as defined by the ATRQ
- are currently on their last failed currently prescribed permitted baseline antidepressant medication
- have a response to their currently prescribed antidepressant noted as depression that has improved ≤49% as defined by the ATRQ.
- agree to, and are eligible for all biomarker assessments (EEG, neurocognitive testing, activity and sleep monitoring, genetic testing). To participate in the activity and sleep monitoring biomarkers, all participants will be required to have a smart phone or an internet enabled tablet. A participant who otherwise qualifies may refuse the salivary genetic sample and be included in the study.
- fluent in English
- willing to comply with all study procedures (with the notes above), able to complete all assessments independently, and available for the duration of the study.
Exclusion Criteria:
Any of the following medical conditions:
- hepatic impairment (i.e., cirrhosis or active/chronic liver disease)
- baseline serum transaminase levels that exceed 2x upper limit of normal(ULN)
- severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks.
- any contraindications to EEG (i.e., requiring high concentration oxygen)
- active suicidal ideation as assessed by the investigator.
- moderate to severe Alcohol Use Disorder (AUD)
Concurrent use of any of the following at baseline (Visit 2):
- tricyclic antidepressants (TCAs), mirtazapine, or monoamine oxidase inhibitors (MAOIs)
- melatonin, ramelteon, or other melatonin agonist
- a potent CYP1A2 inhibitor (e.g., fluvoxamine and ciprofloxacin)
- antipsychotics or mood stabilizers
- hypnotics, anxiolytics, stimulants, or opiate pain medications greater than three days per week and unable to reduce use to 3 or fewer days per week on an as needed basis
Have received electroconvulsive therapy (ECT), deep brain stimulation (DBS),vagus nerve stimulation (VNS), >2 treatments with ketamine, or esketamine in thecurrent depressive episode.
Diagnosis of bipolar disorder or a psychotic disorder based on the SCID forDSM-5
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ALTO-300
ALTO-300 tablet PO; daily dosing 8 weeks
|
One tablet daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To understand the relationship between baseline biology and clinical outcome to ALTO-300 using the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Measured 6 times over 8 weeks
|
The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression.
Possible scores for this 10 item version range from 0 to 60.
The change from baseline to the end of the study is the primary outcome.
|
Measured 6 times over 8 weeks
|
To understand the relationship between baseline biology and clinical outcome to ALTO-300 using the Clinical Global Impression scale - Severity (CGI-S)
Time Frame: Measured 6 times over 8 weeks
|
The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness.
Possible scores for this scale range from 1 to 7. The change from baseline to the end of the study is the primary outcome.
|
Measured 6 times over 8 weeks
|
To evaluate the safety of ALTO-300
Time Frame: From the signing of the ICF until the follow-up visit (up to 12 weeks)
|
Incidence, severity, and relatedness of TEAEs,SAEs, discontinuation due to TEAEs, and deaths
|
From the signing of the ICF until the follow-up visit (up to 12 weeks)
|
To evaluate the safety of ALTO-300
Time Frame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)
|
Assessment of vital signs and laboratory data, withparticular attention to liver function tests
|
From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2021
Primary Completion (Actual)
May 5, 2023
Study Completion (Actual)
May 9, 2023
Study Registration Dates
First Submitted
October 18, 2021
First Submitted That Met QC Criteria
November 2, 2021
First Posted (Actual)
November 12, 2021
Study Record Updates
Last Update Posted (Actual)
May 22, 2023
Last Update Submitted That Met QC Criteria
May 19, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALTO-300-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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