Major Depressive DisorderPhase 1NCT01380704
Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder
A Phase 1 study testing ABT-436 in people with Major Depressive Disorder, run by AbbVie.
Trial summary
This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ABT-436
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Sep 2011
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Age between 18 to 55 years, inclusive. 2. Body Mass Index is 20 to 35 kg/m2, inclusive. 3. A primary Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of major depressive disorder.
- 4. Mild-to-moderate depressive symptoms at Screening. 5. A condition of general good physical health. Exclusion Criteria
- Pregnant or breast-feeding female.
- Use of any medication within 4 weeks prior to Day -2, unless the dose has been stable for 4 weeks, no dose change is anticipated during the study, and the medication is specifically allowed for this study, OR prior as needed (PRN) use of the medication is specifically allowed for this study.
- Use of fluoxetine or aripiprazole within 8 weeks prior to Day -2.
- Positive screen for drugs of abuse/alcohol, recent history of drug/alcohol abuse or smoking.
- A current or past history of major depressive disorder with psychotic features, bipolar disorder, schizophrenia or other psychotic disorder, mental retardation, or mental disorder due to a general medical condition.
Who cannot join
None listed.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of ABT-436 in Major Depressive Disorder Subjects
This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study.
Read the detailed description
This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study. Fifty subjects will receive study drug for seven days. Thirty subjects will receive ABT-436 and twenty subjects will receive placebo. Blood, urine and saliva samples will be obtained, both before and during study drug administration, to measure ABT-436 pharmacology. Safety will be assessed throughout the study, including at two follow-up visits after completion of study drug administration.
- Conditions
- Major Depressive Disorder
- Being tested
- ABT-436, Matching Placebo
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-436Drug
QD Days 1-7
Matching PlaceboDrug
QD Days 1-7
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: ABT-436 |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacology assays
Hormones in blood, urine and saliva samples
Measured: Days -2, -1, 6, 7
ABT-436 drug levels
ABT-436 drug levels in plasma
Measured: Days 6, 7
Vital signs
Blood pressure, pulse
Measured: Days -2 through 8, 14, 30
Clinical safety labs
Hematology, chemistry, urinalysis
Measured: Days -2, 2, 5, 8
Secondary outcomes (1)
Psychiatric symptom scales
Hamilton depression scale, Mood and anxiety symptom questionnaire, Perceived stress scale
Measured: Days -2, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
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.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine Tracy, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380704
- Sponsor's protocol ID
- M12-674
- Status last verified
- Nov 2011
- First submitted
- 1 Jun 2011
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Katz DA, Locke C, Greco N, Liu W, Tracy KA. Hypothalamic-pituitary-adrenal axis and depression symptom effects of an arginine vasopressin type 1B receptor antagonist in a one-week randomized Phase 1b trial. Brain Behav. 2017 Feb 9;7(3):e00628. doi: 10.1002/brb3.628. eCollection 2017 Mar.
PubMed 28293470
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of ABT-436 in Major Depressive Disorder Subjects
- ClinicalTrials.gov ID
- NCT01380704
- Acronym / sponsor ID
- M12-674
- Conditions
- Major Depressive Disorder
- Keywords
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jun 2011 (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.
This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study.
Detailed description
This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study. Fifty subjects will receive study drug for seven days. Thirty subjects will receive ABT-436 and twenty subjects will receive placebo. Blood, urine and saliva samples will be obtained, both before and during study drug administration, to measure ABT-436 pharmacology. Safety will be assessed throughout the study, including at two follow-up visits after completion of study drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: ABT-436 |
| Placebo | Placebo comparator | Drug: Matching Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Age between 18 to 55 years, inclusive. 2. Body Mass Index is 20 to 35 kg/m2, inclusive. 3. A primary Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of major depressive disorder.
- 4. Mild-to-moderate depressive symptoms at Screening. 5. A condition of general good physical health. Exclusion Criteria
- Pregnant or breast-feeding female.
- Use of any medication within 4 weeks prior to Day -2, unless the dose has been stable for 4 weeks, no dose change is anticipated during the study, and the medication is specifically allowed for this study, OR prior as needed (PRN) use of the medication is specifically allowed for this study.
- Use of fluoxetine or aripiprazole within 8 weeks prior to Day -2.
Key exclusion criteria (0 listed)
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-436QD Days 1-7 | Drug | Active |
| Matching PlaceboQD Days 1-7 | Drug | Placebo |
Primary outcome
Pharmacology assays
Time frame: Days -2, -1, 6, 7
Hormones in blood, urine and saliva samples
ABT-436 drug levels
Time frame: Days 6, 7
ABT-436 drug levels in plasma
Vital signs
Time frame: Days -2 through 8, 14, 30
Blood pressure, pulse
Clinical safety labs
Time frame: Days -2, 2, 5, 8
Hematology, chemistry, urinalysis
1 secondary outcome
Psychiatric symptom scales
Time frame: Days -2, 7
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 21 Nov 2017.
- Results publication: PubMed 28293470Katz DA, Locke C, Greco N, Liu W, Tracy KA. Hypothalamic-pituitary-adrenal axis and depression symptom effects of an arginine vasopressin type 1B receptor antagonist in a one-week randomized Phase 1b trial. Brain Behav. 2017 Feb 9;7(3):e00628. doi: 10.1002/brb3.628. eCollection 2017 Mar.
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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.
Katherine Tracy, MD study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-436 in people with Major Depressive Disorder, run by AbbVie.
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 7 inclusion and 0 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacology assays (time frame: Days -2, -1, 6, 7). The study lists 4 primary outcomes in all. 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 NCT01380704, 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 21 Nov 2017.