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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.
 
ClinicalTrials.gov Identifier: NCT00276978
Recruitment Status : Terminated
First Posted : January 13, 2006
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Claus Normann, University Hospital Freiburg

Tracking Information
First Submitted Date  ICMJE January 11, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE June 2005
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
rate of response as defined by a more or equal 50 % reduction of baseline HAM-D (Hamilton Depression Rating scale) [ Time Frame: 4 wks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
rate of response as defined by a more or equal 50 % reduction of baseline HAM-D (Hamilton Depression Rating scale)
Change History Complete list of historical versions of study NCT00276978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
  • -rate of remission (HAM-D less or equal 7)
  • -pre-post-comparison of HAM-D total scores
  • -pre-post-comparison of MADRS (Montgomery Asperg Depression Rating Scale) and CGI (Clinical Global Impression)scores
  • -predictive value of HAM-D subscales for treatment response (e.g. agitation, psychotic fear)
  • -use of comedication
  • -survival in study
  • -adverse events, weight
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aripiprazole Augmentation Therapy in Treatment-resistant Depression
Official Title  ICMJE Aripiprazole Augmentation Therapy in Treatment-resistant Depression
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Therapy-resistant Depression
Intervention  ICMJE Drug: Aripiprazole
Addition of Aripiprazole 10 mg to concurrent medication
Other Name: Abilify
Study Arms  ICMJE Experimental: Aripiprazole
Aripiprazol augmentation therapy
Intervention: Drug: Aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 11, 2006)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276978
Other Study ID Numbers  ICMJE Aripiprazole Augmentation
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claus Normann, University Hospital Freiburg
Study Sponsor  ICMJE University Hospital Freiburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claus Normann, MD Department of Psychiatry, University of Freiburg
PRS Account University Hospital Freiburg
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP