Olanzapine Augmentation Therapy in Treatment-Resistant Depression: a Double-Blind Placebo-Controlled Trial
Information source: University Hospital Freiburg
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Therapy-Resistant Depression
Intervention: Olanzapine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Hospital Freiburg Official(s) and/or principal investigator(s):
Claus Normann, MD, Principal Investigator, Affiliation: Department of Psychiatry, University of Freiburg
Overall contact:
Claus Normann, MD, Phone: ++497612706634, Email: claus.normann@uniklinik-freiburg.de
Summary
60 patients with major depression will be treated with 10 mg Olanzapine or Placebo for 2
weeks. In case of response (reduction of depressive symptoms)the study will be continued for
further 60 days.
Clinical Details
Official title: Olanzapine Augmentation Therapy in Treatment-Resistant Depression: a Double-Blind Placebo-Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Hamilton-Depression-Scale- HAM-D
Secondary outcome: rate of remission (HAM-D less or equal 7)differences in HAM-D total scores differences in MADRS (Montgomery Asberg Depression Rating Scale)and CGI (Clinical Global Impression)scores predictive value of HAM-D subscales for treatment response use of comedication survival in study differences in rates of adverse events, weight differences in HAM-D scores and survival in extension phase
Detailed description:
The study is using a randomized double-blind, parallel-group, placebo-controlled design. 30
patients per treatment group will be included into the study and randomized to the treatment
groups using a computer program. 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, 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 a double-blind therapy of
either 10 mg/d olanzapine or placebo. Study visits will be performed on days 4, 7, and 14
(visits 2-4: vital signs, HAMD, MADRS, CGI, lab).
After 14 days, the patients will be classified as responders or non-responders. A responder
is defined by a reduction of the initial HAM-D score of more than 50%. Study treatment will
be stopped in non-responders and continued in a double-blind manner in responders for
further 60 days. Thereafter, the the study medication is stopped and the patients are
observed for further 14 days. Study visits will be performed every 14 days. This extension
phase was added to examine if a prolonged treatment with olanzapine could ensure a sustained
treatment effect. It should be excluded that olanzapine has a short-term tranquillizer-like
effect or leads to unfavourable medium- to-long-term depressiogenic effects as observed with
other neuroleptics used in depression ( e. g. fluspirilene). Moreover, withdrawal effects
should be excluded.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- major depression without psychotic features
- therapy resistance (2 courses of antidepressants from different classes for more than
3 weeks in adequate dose
- HAM-D score greater/equal than 17
- age 18-65
Exclusion Criteria:
- bipolar disorder
- active alcohol or illicit drug use
- female with ineffective contraception
- severe medical conditions, epilepsy
- psychotic features
Locations and Contacts
Claus Normann, MD, Phone: ++497612706634, Email: claus.normann@uniklinik-freiburg.de
Dept. of Psychiatry, University of Freiburg, Freiburg 79104, Germany; Recruiting
Claus Normann, MD, Phone: ++497612706501, Email: claus.normann@uniklinik-freiburg.de
Additional Information
Starting date: June 2005
Ending date: December 2009
Last updated: February 17, 2009
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