MedPath

Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

Phase 4
Completed
Conditions
Major Depressive Disorder Without Psychotic Features
Interventions
Drug: Asenapine 5-20 mg daily
Drug: Placebo 1-4 tablets daily
Registration Number
NCT01670019
Lead Sponsor
Duke University
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
46
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Asenapine 5-20 mg dailyAsenapine 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 dailyPlacebo 1-4 tablets dailyMatched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Primary Outcome Measures
NameTimeMethod
Change in MADRS Total ScoreBaseline, 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.

Secondary Outcome Measures
NameTimeMethod
Clinical Remission Rate6 weeks

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.

Study Completion Rate6 weeks

The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks

Rates of Sustained Remission2, 4, 6 weeks

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.

Clinical Response RateBaseline, 6 weeks

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.

Trial Locations

Locations (5)

Georgia Health Sciences University

🇺🇸

Augusta, Georgia, United States

Brody School of Medicine at East Carolina University

🇺🇸

Greenville, North Carolina, United States

North Carolina Psychiatric Research Center

🇺🇸

Raleigh, North Carolina, United States

Carolina Behavioral Care

🇺🇸

Durham, North Carolina, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

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