Aripiprazole Augmentation Therapy in Treatment-resistant Depression

August 8, 2022 updated by: Claus Normann, University Hospital Freiburg
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany, D-79104
        • Dept. of Psychiatry, University of Freiburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aripiprazole
Aripiprazol augmentation therapy
Drug: Aripiprazole
Addition of Aripiprazole 10 mg to concurrent medication
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Freiburg

Investigators

  • Principal Investigator: Claus Normann, MD, Department of Psychiatry, University of Freiburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aripiprazole Augmentation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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