Aripiprazole Augmentation Therapy in Treatment-resistant Depression

NCT ID: NCT00276978

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2009-11-30

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.

Conditions

Therapy-resistant Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole

Aripiprazol augmentation therapy

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Addition of Aripiprazole 10 mg to concurrent medication

Interventions

Aripiprazole

Addition of Aripiprazole 10 mg to concurrent medication

Intervention Type: DRUG

Other Intervention Names

Abilify

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Freiburg

OTHER

Sponsor Role: lead

Responsible Party

Claus Normann

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claus Normann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, University of Freiburg

Locations

Dept. of Psychiatry, University of Freiburg

Freiburg im Breisgau, , Germany

Countries

Germany

Other Identifiers

Aripiprazole Augmentation

Identifier Type: -

Identifier Source: org_study_id