Aripiprazole Augmentation Therapy in Treatment-resistant Depression

Therapy-resistant Depression Clinical Trial

Official title:

Aripiprazole Augmentation Therapy in Treatment-resistant Depression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00276978
• Other study ID #: Aripiprazole Augmentation
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2005
• Est. completion date: November 2009

Study information

• Verified date: August 2022
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Therapy-resistant Depression

Intervention

Drug:
• Aripiprazole
Addition of Aripiprazole 10 mg to concurrent medication

Locations

Country	Name	City	State
Germany	Dept. of Psychiatry, University of Freiburg	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of response as defined by a more or equal 50 % reduction of baseline HAM-D (Hamilton Depression Rating scale)		4 wks