Major Depressive DisorderPhase 2ELEVATENCT03078322
AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression
A Phase 2 study testing AV-101 in people with Major Depressive Disorder, run by VistaGen Therapeutics, Inc. at 22 sites in United States.
Trial summary
The study will evaluate the safety and efficacy of AV-101. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- AV-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 22 sitesUnited States
- Study dates
- 5 Mar 2018to 1 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with MDD, single or recurrent, and currently experiencing a MDE of at least 8 weeks in duration.
- Has a history of inadequate response to at least 1 approved antidepressant including at least 1 and no more than 3 during the current depressive episode.
- Meet the threshold on the total HAMD-17 score of > 20
- If female, a status of nonchildbearing potential or use of an acceptable form of birth control.
- Body mass index between 18 to 40 kg/m2.
- Other criteria may apply
Who cannot join
- History of bipolar disorder, schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within 6 months prior to screening.
- Women who are pregnant or breastfeeding or a positive pregnancy test at screening or baseline.
- Currently taking a prohibited adjunct therapy. Such drugs must be washed out for at least 4 weeks prior to baseline.
- Current diagnosis of moderate or severe substance use (including alcohol) disorder (abuse or dependence, as defined by DSM-5), with the exception of nicotine dependence, at screening or within 6 months prior to screening.
- In the opinion of the investigator, the subject has a significant risk for suicidal behavior
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- Has received electroconvulsive therapy, or had repetitive transcranial magnetic stimulation in the current episode.
- Has received vagus nerve stimulation at any time prior to screening.
- Any current or past history of any physical condition, which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
VistaGen Investigational Site
Atlanta, Georgia, 30331
VistaGen Investigational Site
Augusta, Georgia, 30912
VistaGen Investigational Site
Bellevue, Washington, 98007
VistaGen Investigational Site
Dayton, Ohio, 45417
VistaGen Investigational Site
Fort Myers, Florida, 33912
VistaGen Investigational Site
Gaithersburg, Maryland, 20877
VistaGen Investigational Site
Garden Grove, California, 92845
VistaGen Investigational Site
Hoffman Estates, Illinois, 60169
VistaGen Investigational Site
Houston, Texas, 77030
VistaGen Investigational Site
Houston, Texas, 77058
VistaGen Investigational Site
Jacksonville, Florida, 32256
VistaGen Investigational Site
Lake Charles, Louisiana, 70629
VistaGen Investigational Site
Los Angeles, California, 90024
VistaGen Investigational Site
Media, Pennsylvania, 19063
VistaGen Investigational Site
National City, California, 91950
VistaGen Investigational Site
New York, New York, 10128
VistaGen Investigational Site
Oakland, California, 94607
VistaGen Investigational Site
Oklahoma City, Oklahoma, 73112
VistaGen Investigational Site
Rochester, New York, 14618
VistaGen Investigational Site
San Diego, California, 92103
VistaGen Investigational Site
St Louis, Missouri, 63141
VistaGen Investigational Site
Temecula, California, 92591
About this study
Official title: Double-Blind, Placebo-Controlled, Phase 2 Trial to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) as Adjunct to Current Antidepressant Therapy in Patients With Major Depressive Disorder (the ELEVATE Study)
The study will evaluate the safety and efficacy of AV-101.
- Conditions
- Major Depressive Disorder
- Being tested
- AV-101, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-101Drug
Also called L-4-chlorokynurenine
Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
PlaceboDrug
Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
| Study group | Role | What they receive |
|---|---|---|
| AV-101 | Experimental | L-4-chlorokynurenine 1440 mg daily for 14 days Receives: Drug: AV-101 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)
Depression questionnaire
Measured: 2 weeks
Secondary outcomes (2)
Time course of improvement including response rates
50% improvement on MADRS-10
Measured: 2 weeks
Safety and tolerability will be assessed by incidence of adverse events (AEs)
Also include EKG, labs etc.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start5 Mar 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- VistaGen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078322
- Sponsor's protocol ID
- VSG-CL 003
- Acronym
- ELEVATE
- Status last verified
- Oct 2019
- First submitted
- 8 Mar 2017
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel W, Shankar RG, Smith MA, Snodgrass HR, Pirmohamed M, Jorgensen AL, Alfirevic A, Dickens D. Role of Transporters and Enzymes in Metabolism and Distribution of 4-Chlorokynurenine (AV-101). Mol Pharm. 2024 Feb 5;21(2):550-563. doi: 10.1021/acs.molpharmaceut.3c00700. Epub 2024 Jan 23.
PubMed 38261609
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Phase 2 Trial to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) as Adjunct to Current Antidepressant Therapy in Patients With Major Depressive Disorder (the ELEVATE Study)
- ClinicalTrials.gov ID
- NCT03078322
- Acronym / sponsor ID
- ELEVATE / VSG-CL 003
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- VistaGen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the safety and efficacy of AV-101.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AV-101 | Experimental | Drug: AV-101L-4-chlorokynurenine 1440 mg daily for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with MDD, single or recurrent, and currently experiencing a MDE of at least 8 weeks in duration.
- Has a history of inadequate response to at least 1 approved antidepressant including at least 1 and no more than 3 during the current depressive episode.
- Meet the threshold on the total HAMD-17 score of > 20
- If female, a status of nonchildbearing potential or use of an acceptable form of birth control.
- Body mass index between 18 to 40 kg/m2.
Key exclusion criteria (9 listed)
- History of bipolar disorder, schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within 6 months prior to screening.
- Women who are pregnant or breastfeeding or a positive pregnancy test at screening or baseline.
- Currently taking a prohibited adjunct therapy. Such drugs must be washed out for at least 4 weeks prior to baseline.
- Current diagnosis of moderate or severe substance use (including alcohol) disorder (abuse or dependence, as defined by DSM-5), with the exception of nicotine dependence, at screening or within 6 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-101Also: L-4-chlorokynurenineOral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant) | Drug | AV-101 |
| PlaceboOral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant) | Drug | Placebo |
Primary outcome
Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)
Time frame: 2 weeks
Depression questionnaire
2 secondary outcomes
Time course of improvement including response rates
Time frame: 2 weeks
Safety and tolerability will be assessed by incidence of adverse events (AEs)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 38261609Patel W, Shankar RG, Smith MA, Snodgrass HR, Pirmohamed M, Jorgensen AL, Alfirevic A, Dickens D. Role of Transporters and Enzymes in Metabolism and Distribution of 4-Chlorokynurenine (AV-101). Mol Pharm. 2024 Feb 5;21(2):550-563. doi: 10.1021/acs.molpharmaceut.3c00700. Epub 2024 Jan 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AV-101 in people with Major Depressive Disorder, run by VistaGen Therapeutics, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03078322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.