Major Depressive Disorder Without Psychotic Features Clinical Trial
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
| Verified date | August 2015 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | June 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: -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: 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 or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline 10. Hepatic impairment and history of low WBC, by medical history and interview. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Georgia Health Sciences University | Augusta | Georgia |
| United States | Carolina Behavioral Care | Durham | North Carolina |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Brody School of Medicine at East Carolina University | Greenville | North Carolina |
| United States | North Carolina Psychiatric Research Center | Raleigh | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | Merck Sharp & Dohme Corp. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
Baseline, 6 weeks | No |
| Secondary | Study Completion Rate | The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks | 6 weeks | No |
| Secondary | 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. |
Baseline, 6 weeks | No |
| Secondary | 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. |
6 weeks | No |
| Secondary | 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. |
2, 4, 6 weeks | No |