- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00276978
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Withdrawn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
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Freiburg, Germany, D-79104
- Dept. of Psychiatry, University of Freiburg
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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
|
Addition of Aripiprazole 10 mg to concurrent medication
Other Names:
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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
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
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Treatment-Resistant
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
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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