Study Evaluating DVS-233 SR in Elderly Outpatients With Major Depressive Disorder

Study Overview
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Brief Summary
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To evaluate the overall safety and tolerability profile of two dose levels of DVS-233 SR during 6 months of open-label treatment in elderly outpatients with major depressive disorder.

Official Title
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A 6 Month, Open-Label Evaluation of the Long-Term Safety of DVS-233 SR in Elderly Outpatients With Major Depressive Disorder (MDD)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: DVS-233 SR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients men and women aged 65 years or older. Mini Mental State Examination score of 24 or above. Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features, on study day 1, if depressive symptoms for at least 30 days prior to screening visit and minimum screening and study day -1 (baseline) scores of 16 on the Hamilton Psychiatric Rating Scale for Depression (HAM-D17). Exclusion Criteria: Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention. Current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified Mini International Neuropsychiatric Interview (MINI). Current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified MINI and considered by the investigator to be primary, causing a higher degree of distress or impairment than MDD. Presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic). Presence of dementia. Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder. Other exclusion applies.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233 SR|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long-term safety and tolerability of DVS SR in elderly outpatients with MDD. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long-term response of subjects receiving DVS SR for the clinical global evaluation, functionality, general well-being, pain and absence of depressive symptoms (Hamilton Psychiatric Rating Scale for Depression 17-item score < or = 7). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression