Clinical Trial: Aripiprazole Augmentation Therapy in Treatment-resistant Depression

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: University Hospital Freiburg

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

Current Secondary Outcome:

Original Secondary Outcome:

  • -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


Information By: University Hospital Freiburg

Dates:
Date Received: January 11, 2006
Date Started: June 2005
Date Completion:
Last Updated: May 12, 2016
Last Verified: May 2016