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Aripiprazole Augmentation Therapy in Treatment-resistant Depression

Primary Purpose

Therapy-resistant Depression

Status
Withdrawn
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Therapy-resistant Depression focused on measuring Therapy-resistant Depression, add-on therapy depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Psychiatry, University of Freiburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aripiprazole

Arm Description

Aripiprazol augmentation therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 11, 2006
Last Updated
August 8, 2022
Sponsor
University Hospital Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT00276978
Brief Title
Aripiprazole Augmentation Therapy in Treatment-resistant Depression
Official Title
Aripiprazole Augmentation Therapy in Treatment-resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Initiation of study was stopped due to administrative reasons before first subject was enrolled.
Study Start Date
June 2005 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
November 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Freiburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapy-resistant Depression
Keywords
Therapy-resistant Depression, add-on therapy depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
Aripiprazol augmentation therapy
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Addition of Aripiprazole 10 mg to concurrent medication
Primary Outcome Measure Information:
Title
rate of response as defined by a more or equal 50 % reduction of baseline HAM-D (Hamilton Depression Rating scale)
Time Frame
4 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Normann, MD
Organizational Affiliation
Department of Psychiatry, University of Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Psychiatry, University of Freiburg
City
Freiburg
ZIP/Postal Code
D-79104
Country
Germany

12. IPD Sharing Statement

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Aripiprazole Augmentation Therapy in Treatment-resistant Depression

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