Aripiprazole Augmentation Therapy in Treatment-resistant Depression
Information source: University Hospital Freiburg
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Therapy-resistant Depression
Intervention: Aripiprazole (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Hospital Freiburg Official(s) and/or principal investigator(s): Claus Normann, MD, Principal Investigator, Affiliation: Department of Psychiatry, University of Freiburg
Overall contact: Claus Normann, MD, Phone: ++497612706634, Email: claus_normann@psyallg.ukl.uni-freiburg.de
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.
Clinical Details
Official title: Aripiprazole Augmentation Therapy in Treatment-resistant Depression
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: rate of response as defined by a more or equal 50 % reduction of baseline HAM-D (Hamilton Depression Rating scale)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Claus Normann, MD, Phone: ++497612706634, Email: claus_normann@psyallg.ukl.uni-freiburg.de
Dept. of Psychiatry, University of Freiburg, Freiburg D-79104, Germany; Recruiting Claus Normann, MD, Phone: ++497612706634, Email: claus_normann@psyallg.ukl.uni-freiburg.de Claus Normann, MD, Principal Investigator
Additional Information
Starting date: June 2005
Last updated: January 12, 2010
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