Aripiprazole Augmentation Therapy in Treatment-resistant Depression

Phase 3

Withdrawn

• Conditions: Therapy-resistant Depression
• Interventions: Drug: Aripiprazole

• Registration Number: NCT00276978
• Lead Sponsor: University Hospital Freiburg

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-13
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aripiprazole	Aripiprazole	Aripiprazol augmentation therapy

Primary Outcome Measures

Name	Time	Method
rate of response as defined by a more or equal 50 % reduction of baseline HAM-D (Hamilton Depression Rating scale)	4 wks

Trial Locations

Locations (1)

Dept. of Psychiatry, University of Freiburg; 🇩🇪 Freiburg, Germany