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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

Page last updated: August 20, 2015

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