Major Depressive DisorderPhase 2NCT01741142
Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
A Phase 2 study testing ABT-436 and Escitalopram in people with Major Depressive Disorder, run by AbbVie (prior sponsor, Abbott) at 18 sites in United States.
Trial summary
The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder. 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?
- ABT-436 and Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2012to Aug 2015
- 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
- Has a primary Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision diagnosis of major depressive disorder without psychotic features
- No current antidepressant treatment within 7 half-lives or 2 weeks, whichever is longer, prior to Day minus 1.
- Can safely be treated on an outpatient basis.
- A condition of general good physical health.
- Surgically sterile, using a highly effective method of birth control or (if female) at least 1 year post menopausal.
Who cannot join
- History of hypersensitivity, intolerance or adverse reaction to escitalopram that led to discontinuation, or hypersensitivity to citalopram. History of serotonin syndrome.
- Inadequate response to more than two different antidepressant medications during the current major depressive episode.
- History of electroconvulsive therapy, vagal nerve stimulation or deep brain stimulation.
- History of transcranial magnetic stimulation during the current major depressive episode.
- Psychotherapy that has not been ongoing for at least 3 months prior to Day minus 1.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Site Reference ID/Investigator# 85594
Atlanta, Georgia, 30328
Site Reference ID/Investigator# 87219
Austin, Texas, 78731
Site Reference ID/Investigator# 87215
Bradenton, Florida, 34201
Site Reference ID/Investigator# 87227
Brooklyn, New York, 11235
Site Reference ID/Investigator# 87216
Dallas, Texas, 75231
Site Reference ID/Investigator# 87217
Dayton, Ohio, 45417
Site Reference ID/Investigator# 87228
Garden Grove, California, 92845
Site Reference ID/Investigator# 87933
Houston, Texas, 77008
Site Reference ID/Investigator# 85593
Little Rock, Arkansas, 72211
Site Reference ID/Investigator# 85580
Marlton, New Jersey, 08053
Site Reference ID/Investigator# 87214
National City, California, 91950
Site Reference ID/Investigator# 87223
New York, New York, 10128
Site Reference ID/Investigator# 87220
Oakland, California, 94612
Site Reference ID/Investigator# 87221
Philadelphia, Pennsylvania, 19139
Site Reference ID/Investigator# 87226
Portland, Oregon, 97210
Site Reference ID/Investigator# 88874
Salt Lake City, Utah, 84106
Site Reference ID/Investigator# 88876
Seattle, Washington, 98104
Site Reference ID/Investigator# 87225
South Miami, Florida, 33143
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder
The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.
- Conditions
- Major Depressive Disorder
- Being tested
- ABT-436, Escitalopram, Placebo
- Keywords
- Major Depressive Disorder
- 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.
ABT-436Drug
Subjects receiving ABT-436
EscitalopramDrug
Subjects receiving escitalopram
PlaceboDrug
Subject receiving placebo
| Study group | Role | What they receive |
|---|---|---|
| ABT-436 | Experimental | Subject receiving ABT-436 Receives: Drug: ABT-436 |
| Escitalopram | Active comparator | Subject receiving escitalopram. Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | Subject receiving placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Measured: Week 6
Secondary outcomes (1)
Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.
Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2013 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: Decision based on strategic determination; not safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beatrice Rendenbach-Mueller, PhD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741142
- Sponsor's protocol ID
- M11-733
- Status last verified
- Oct 2013
- First submitted
- 30 Nov 2012
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01741142
- Acronym / sponsor ID
- M11-733
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision based on strategic determination; not safety.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 4 Dec 2012 (estimated)
- 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 purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABT-436 | Experimental | Drug: ABT-436Subject receiving ABT-436 |
| Escitalopram | Active comparator | Drug: EscitalopramSubject receiving escitalopram. |
| Placebo | Placebo comparator | Drug: PlaceboSubject receiving placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a primary Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision diagnosis of major depressive disorder without psychotic features
- No current antidepressant treatment within 7 half-lives or 2 weeks, whichever is longer, prior to Day minus 1.
- Can safely be treated on an outpatient basis.
- A condition of general good physical health.
- Surgically sterile, using a highly effective method of birth control or (if female) at least 1 year post menopausal.
Key exclusion criteria (5 listed)
- History of hypersensitivity, intolerance or adverse reaction to escitalopram that led to discontinuation, or hypersensitivity to citalopram. History of serotonin syndrome.
- Inadequate response to more than two different antidepressant medications during the current major depressive episode.
- History of electroconvulsive therapy, vagal nerve stimulation or deep brain stimulation.
- History of transcranial magnetic stimulation during the current major depressive episode.
- Psychotherapy that has not been ongoing for at least 3 months prior to Day minus 1.
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 |
|---|---|---|
| ABT-436Subjects receiving ABT-436 | Drug | ABT-436 |
| EscitalopramSubjects receiving escitalopram | Drug | Escitalopram |
| PlaceboSubject receiving placebo | Drug | Placebo |
Primary outcome
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Time frame: Week 6
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
1 secondary outcome
Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.
Time frame: Week 6
Results and safety
The study was stopped early (reason given: Decision based on strategic determination; not safety.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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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.
Beatrice Rendenbach-Mueller, PhD study director
AbbVie
18 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 ABT-436 and Escitalopram in people with Major Depressive Disorder, run by AbbVie (prior sponsor, Abbott) at 18 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 was stopped early (reason given: Decision based on strategic determination; not safety.). Results are not available in the source record.
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?
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score. (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2013.