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Sponsored by: |
University Hospital Freiburg |
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Information provided by: | University Hospital Freiburg |
ClinicalTrials.gov Identifier: | NCT00273624 |
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.
Condition | Intervention | Phase |
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Therapy-Resistant Depression |
Drug: Olanzapine Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Olanzapine Augmentation Therapy in Treatment-Resistant Depression: a Double-Blind Placebo-Controlled Trial |
Estimated Enrollment: | 60 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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olanzapine: Experimental
10 mg Olanzapine
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Drug: Olanzapine
10 mg Olanzapin concurrent to antidepressive medication
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placebo: Placebo Comparator
Placebo
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Drug: Placebo
placebo
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Claus Normann, MD | ++497612706634 | claus.normann@uniklinik-freiburg.de |
Germany | |
Dept. of Psychiatry, University of Freiburg | Recruiting |
Freiburg, Germany, 79104 | |
Contact: Claus Normann, MD ++497612706501 claus.normann@uniklinik-freiburg.de |
Principal Investigator: | Claus Normann, MD | Department of Psychiatry, University of Freiburg |
Responsible Party: | Dept. Of Psychiatry University of Freiburg ( Dr. Claus Normann ) |
Study ID Numbers: | Olanzapine Augmentation |
Study First Received: | January 4, 2006 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00273624 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Therapy-resistant depression add-on therapy depression |
Neurotransmitter Agents Depression Tranquilizing Agents Olanzapine Psychotropic Drugs Antiemetics Central Nervous System Depressants Depressive Disorder |
Antipsychotic Agents Serotonin Uptake Inhibitors Serotonin Behavioral Symptoms Mental Disorders Mood Disorders Peripheral Nervous System Agents |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Depression Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Olanzapine Antiemetics Central Nervous System Depressants Depressive Disorder |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Serotonin Agents Autonomic Agents Mental Disorders Therapeutic Uses Mood Disorders Peripheral Nervous System Agents Central Nervous System Agents |