This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Olanzapine Augmentation Therapy in Treatment-resistant Depression: a Double-blind Placebo-controlled Trial

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Claus Normann, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00273624
First received: January 4, 2006
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
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
Therapy-resistant Depression Drug: Olanzapine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Olanzapine Augmentation Therapy in Treatment-resistant Depression: a Double-blind Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Claus Normann, University Hospital Freiburg:

Primary Outcome Measures:
  • Hamilton-Depression-Scale- HAM-D [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • rate of remission (HAM-D less or equal 7) [ Time Frame: 14 days ]
  • differences in HAM-D total scores [ Time Frame: 14 days ]
  • differences in MADRS (Montgomery Asberg Depression Rating Scale)and CGI (Clinical Global Impression)scores [ Time Frame: 14 days ]
  • predictive value of HAM-D subscales for treatment response use of comedication [ Time Frame: 14 days ]
  • survival in study [ Time Frame: 14 days ]
  • differences in rates of adverse events, weight [ Time Frame: 14 days ]
  • differences in HAM-D scores and survival in extension phase [ Time Frame: 2 months ]

Enrollment: 60
Study Start Date: June 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: olanzapine
10 mg Olanzapine
Drug: Olanzapine
10 mg Olanzapin concurrent to antidepressive medication
Other Name: Zyprexa
Placebo Comparator: placebo
Placebo
Drug: Placebo
placebo

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273624

Locations
Germany
Dept. of Psychiatry, University of Freiburg
Freiburg, Germany, 79104
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Claus Normann, MD Department of Psychiatry, University of Freiburg
  More Information

Responsible Party: Claus Normann, Prof. Dr., University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT00273624     History of Changes
Other Study ID Numbers: Olanzapine Augmentation
Study First Received: January 4, 2006
Last Updated: May 12, 2016

Keywords provided by Claus Normann, University Hospital Freiburg:
Therapy-resistant depression
add-on therapy depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents

ClinicalTrials.gov processed this record on June 26, 2017