Major Depressive Disorder Without Psychotic FeaturesPhase 4NCT01670019
Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
A Phase 4 study testing Asenapine 5-20 mg daily in people with Major Depressive Disorder Without Psychotic Features, run by Duke University at 5 sites in United States.
Trial summary
This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder Without Psychotic Features
- What is being tested?
- Asenapine 5-20 mg daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2012to Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- -130 male or female patients, 18-65 years of age, with:
- DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI)
- MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization
- Inadequate therapeutic response during their current depressive episode; an inadequate therapeutic response will be defined as continued depressive psychopathology (see criterion 2) following > six weeks of therapy at adequate doses (according to the US label) of any non-tricyclic, non-MAOI antidepressant medication
Who cannot join
- Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to enrollment
- DSM-IV Axis II diagnoses that significantly impact the current psychiatric status
- Current MDD episode lasting > 12 months
- Electroconvulsive therapy within the preceding 6 months
- Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment
- Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE <24)
Show all 10Show fewer
- Risk of suicide as defined by MADRS item 10 score > 4
- Prior failure to respond to asenapine
- Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline
- Hepatic impairment and history of low WBC, by medical history and interview.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Georgia Health Sciences University
Augusta, Georgia, 30912
Carolina Behavioral Care
Durham, North Carolina, 27704
Duke University Medical Center
Durham, North Carolina, 27710
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
North Carolina Psychiatric Research Center
Raleigh, North Carolina, 27603
About this study
Official title: A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy
This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone.
The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.
Read the detailed description
The investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone.
- Being tested
- Asenapine 5-20 mg daily, Placebo 1-4 tablets daily
- Keywords
- Depression, Antidepressant, Antipsychotic
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asenapine 5-20 mg dailyDrug
Also called SAPHRIS
5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID
Placebo 1-4 tablets dailyDrug
Also called Placebo
One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
| Study group | Role | What they receive |
|---|---|---|
| Asenapine 5-20 mg daily | Experimental | Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Receives: Drug: Asenapine 5-20 mg daily |
| Placebo 1-4 tablets daily | Placebo comparator | Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Receives: Drug: Placebo 1-4 tablets daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS Total Score
The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.
MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Measured: Baseline, 6 weeks
Secondary outcomes (4)
Study Completion Rate
The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks
Measured: 6 weeks
Clinical Response Rate
Clinical Response rate will be defined as the number of participants with a > 50% reduction from baseline in MADRS total score.
MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Measured: Baseline, 6 weeks
Clinical Remission Rate
Clinical Remission will be defined as the number of participants with a MADRS total score < 7.
MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Measured: 6 weeks
Rates of Sustained Remission
Sustained remission will be defined as at least two consecutive post-randomization assessments (weeks 2, 4, and 6) during which minimal depressive psychopathology (MADRS < 7) is present.
MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Measured: 2, 4, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive Disorder Without Psychotic FeaturesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- John Beyer, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670019
- Sponsor's protocol ID
- Pro00037462
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2012
- Last updated
- 1 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy
- ClinicalTrials.gov ID
- NCT01670019
- Acronym / sponsor ID
- Pro00037462
- Keywords
- Depression, Antidepressant, Antipsychotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Posted 1 Oct 2015
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 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone.
The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.
Detailed description
The investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone.
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 |
|---|---|---|
| Asenapine 5-20 mg daily | Experimental | Drug: Asenapine 5-20 mg dailyAsenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability |
| Placebo 1-4 tablets daily | Placebo comparator | Drug: Placebo 1-4 tablets dailyMatched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI)
- MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization
- Inadequate therapeutic response during their current depressive episode; an inadequate therapeutic response will be defined as continued depressive psychopathology (see criterion 2) following > six weeks of therapy at adequate doses (according to the US label) of any non-tricyclic, non-MAOI antidepressant medication
Key exclusion criteria (10 listed)
- Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to enrollment
- DSM-IV Axis II diagnoses that significantly impact the current psychiatric status
- Current MDD episode lasting > 12 months
- Electroconvulsive therapy within the preceding 6 months
- Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment
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 |
|---|---|---|
| Asenapine 5-20 mg dailyAlso: SAPHRIS5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID | Drug | Asenapine 5-20 mg daily |
| Placebo 1-4 tablets dailyAlso: PlaceboOne placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID | Drug | Placebo 1-4 tablets daily |
Primary outcome
Change in MADRS Total Score
Time frame: Baseline, 6 weeks
The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
4 secondary outcomes
Study Completion Rate
Time frame: 6 weeks
Clinical Response Rate
Time frame: Baseline, 6 weeks
Clinical Remission Rate
Time frame: 6 weeks
Rates of Sustained Remission
Time frame: 2, 4, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
John Beyer, MD principal investigator
Duke University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Asenapine 5-20 mg daily in people with Major Depressive Disorder Without Psychotic Features, run by Duke University at 5 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 4 inclusion and 10 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 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in MADRS Total Score (time frame: Baseline, 6 weeks). 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 1 Oct 2015.