Aripiprazole Augmentation Therapy in Treatment-resistant Depression

Study Overview
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Brief Summary
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20 therapy-refractory patients with major depression will be treated for 3 weeks with Aripiprazole 10 mg/d. Effectivity will be assessed using a pre-post comparison of different psychopathological rating scales and patient adherence.

Detailed Description
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This will be an open pilot study using pre-post comparison. 20 treatment-refractory patients with major depression diagnosed by DSM-IV will be included. Psychotic features of depression will be excluded by a score of 2 or less in the PANSS subscales P1, P3 and P6. Treatment resistance as defined by history of non-response to two antidepressants from different classes at an acceptable dose and period is confirmed retrospectively. If possible, treatment compliance should be confirmed by plasma level examination. After informed consent, visit 1 is performed on day 0 (inclusion criteria, history, demographics, physical examination, vital signs, HAMD, MADRS, CGI, BDI, lab). Study medication is started on day 1, the antidepressive therapy is continued at stable dose until the end of the study. Patients will receive an adjunctive augmentation therapy of 10 mg/d aripiprazole. Study visits will be performed on days 3, 7, 14 and 21 (visits 2-5: vital signs, HAMD, MADRS, CGI, BDI, lab). In addition to the HAM-D and MADRS scores, patients will perform a self-rating (BDI). Aripiprazole plasma levels will be measured at the end of the treatment period to assess compliance and to detect a putative correlation between drug plasma levels and efficacy.

Official Title
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Aripiprazole Augmentation Therapy in Treatment-resistant Depression

Conditions
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Therapy-resistant Depression

Intervention / Treatment
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* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: major depression without psychotic features (DSM-IV definition) therapy resistance (two courses of antidepressants from different classes for more than 3 weeks in adequate dose) HAM-D score greater/equal than 17 age 18-70 Exclusion Criteria: bipolar disorder active alcohol or illicit drug use female without effective contraception severe medical conditions psychotic features

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole<br>Aripiprazol augmentation therapy | Drug: Aripiprazole<br>* Addition of Aripiprazole 10 mg to concurrent medication<br>* Other names: Abilify;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of response as defined by a more or equal 50 % reduction of baseline HAM-D (Hamilton Depression Rating scale) |  | 4 wks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapy-resistant Depression, add-on therapy depression