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Aripiprazole Augmentation Therapy in Treatment-resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276978
Recruitment Status : Terminated
First Posted : January 13, 2006
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
Claus Normann, University Hospital Freiburg

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.

Condition or disease Intervention/treatment Phase
Therapy-resistant Depression Drug: Aripiprazole Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole Augmentation Therapy in Treatment-resistant Depression
Study Start Date : June 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Aripiprazole
Aripiprazol augmentation therapy
Drug: Aripiprazole
Addition of Aripiprazole 10 mg to concurrent medication
Other Name: Abilify

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276978

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Dept. of Psychiatry, University of Freiburg
Freiburg, Germany, D-79104
Sponsors and Collaborators
University Hospital Freiburg
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Principal Investigator: Claus Normann, MD Department of Psychiatry, University of Freiburg

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Responsible Party: Claus Normann, Prof. Dr., University Hospital Freiburg Identifier: NCT00276978     History of Changes
Other Study ID Numbers: Aripiprazole Augmentation
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Keywords provided by Claus Normann, University Hospital Freiburg:
Therapy-resistant Depression
add-on therapy depression
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists