Therapy-resistant Depression
Conditions
Keywords
Therapy-resistant Depression, add-on therapy depression
Brief summary
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
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.
Interventions
DRUGAripiprazole
Addition of Aripiprazole 10 mg to concurrent medication
Sponsors
University Hospital Freiburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of response as defined by a more or equal 50 % reduction of baseline HAM-D (Hamilton Depression Rating scale) | 4 wks |
Countries
Germany
Outcome results
None listed