NCT00276978

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

4.4 years

First QC Date

January 11, 2006

Last Update Submit

August 8, 2022

Conditions

Therapy-resistant Depression

Keywords

Therapy-resistant Depressionadd-on therapy depression

Outcome Measures

Primary Outcomes (1)

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

    4 wks

Study Arms (1)

Aripiprazole

EXPERIMENTAL

Aripiprazol augmentation therapy

Drug: Aripiprazole

Interventions

AripiprazoleDRUG

Addition of Aripiprazole 10 mg to concurrent medication

Also known as: Abilify
Aripiprazole

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • bipolar disorder
  • active alcohol or illicit drug use
  • female without effective contraception
  • severe medical conditions
  • psychotic features

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Psychiatry, University of Freiburg

Freiburg im Breisgau, D-79104, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Claus Normann, MD

    Department of Psychiatry, University of Freiburg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 11, 2006

First Posted

January 13, 2006

Study Start

June 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations

DE(1)