Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
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Purpose
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.
We hypothesize that added asenapine will produce greater reductions in depression than will added placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder Without Psychotic Features |
Drug: Asenapine 5-20 mg daily Drug: Placebo 1-4 tablets daily |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Change in MADRS total score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
10 items
- Study completion rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The percentage of patients still taking their assigned treatment (asenapine or placebo) at the end of 6 weeks
| Estimated Enrollment: | 130 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Asenapine 5-20 mg daily
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
|
Drug: Asenapine 5-20 mg daily
5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID
Other Name: SAPHRIS
|
|
Placebo Comparator: Placebo 1-4 tablets daily
Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
|
Drug: Placebo 1-4 tablets daily
One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Other Name: Placebo
|
Detailed Description:
We 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:We will include 130 male or female patients, 18-65 years of age, with:
1. DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI) 2. MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization 3. 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
-
Exclusion Criteria:We will exclude from study individuals with:
1. 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 2. DSM-IV Axis II diagnoses that significantly impact the current psychiatric status 3. Current MDD episode lasting > 12 months 4. Electroconvulsive therapy within the preceding 6 months 5. Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment 6. Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE <24) 7. Risk of suicide as defined by MADRS item 10 score > 4 8. Prior failure to respond to asenapine 9. Pregnancy as determined by serum pregnancy test at baseline
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Contacts and Locations| Contact: JOSEPH P MCEVOY, MD | 919-819-9295 | JPMCEVOY@DUKE.EDU |
| Contact: WILLIAM H WILSON, PH.D. | 919-575-7360 | WILSO066@MC.DUKE.EDU |
| United States, Georgia | |
| Georgia Health Sciences University | Not yet recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact: Simon C Sebastion, MD 706-721-7178 ssebasti@georgiahealth.edu | |
| Contact: Adriana Foster, MD 706-721-7488 afoster@georgiahealth.edu | |
| United States, North Carolina | |
| Duke University Medical Center | Not yet recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: John L Beyer, MD 919-668-0209 john.beyer@duke.edu | |
| Contact: Nabila Lateef, RN 919-684-9701 nabila.lateef@duke.edu | |
| Principal Investigator: John L Beyer, MD | |
| Carolina Behavioral Care | Not yet recruiting |
| Durham, North Carolina, United States, 27704 | |
| Contact: Robert A Millet, MD 919-972-7700 rmillet@carolinabehavioralcare.com | |
| Contact: Edward S Lueth, MSW 919-972-7700 elueth@carolinabehavioralcare.com | |
| Principal Investigator: Robert A Miller, MD | |
| Brody School of Medicine at East Carolina University | Not yet recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Contact: Nadyah J John, MD 252-744-2673 johnn@ecu.edu | |
| Contact: Richard M Bloch, PhD 252-744-3324 blochri@ecu.edu | |
| Principal Investigator: Nadyah J John, MD | |
| North Carolina Psychiatric Research Center | Not yet recruiting |
| Raleigh, North Carolina, United States, 27603 | |
| Contact: Joy W Smith, RN 919-733-5229 joy.w.smith@dhhs.nc.gov | |
| Contact: Lars F Jarskog, MD 919-715-9157 lars_jarskog@med.unc.edu | |
| Principal Investigator: Lars F Jarskog, MD | |
| Principal Investigator: | Joseph P McEvoy, MD | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01670019 History of Changes |
| Other Study ID Numbers: | Pro00037462 |
| Study First Received: | August 17, 2012 |
| Last Updated: | August 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Depression Antidepressant Antipsychotic |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Mental Disorders Psychotic Disorders Depressive Disorder, Major Behavioral Symptoms Mood Disorders Schizophrenia and Disorders with Psychotic Features Antidepressive Agents |
Asenapine Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013