Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Olanzapine Augmentation Therapy in Treatment-Resistant Depression: a Double-Blind Placebo-Controlled Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00273624
First received: January 4, 2006
Last updated: February 17, 2009
Last verified: February 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University Hospital Freiburg:

Primary Outcome Measures:
  • Hamilton-Depression-Scale- HAM-D [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of remission (HAM-D less or equal 7) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • differences in HAM-D total scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • differences in MADRS (Montgomery Asberg Depression Rating Scale)and CGI (Clinical Global Impression)scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • predictive value of HAM-D subscales for treatment response use of comedication [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • survival in study [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • differences in rates of adverse events, weight [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • differences in HAM-D scores and survival in extension phase [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

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
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
Genders Eligible for Study:   Both
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

Contacts
Contact: Claus Normann, MD ++497612706634 claus.normann@uniklinik-freiburg.de

Locations
Germany
Dept. of Psychiatry, University of Freiburg Recruiting
Freiburg, Germany, 79104
Contact: Claus Normann, MD    ++497612706501    claus.normann@uniklinik-freiburg.de   
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Claus Normann, MD Department of Psychiatry, University of Freiburg
  More Information

No publications provided

Responsible Party: Dr. Claus Normann, Dept. Of Psychiatry University of Freiburg
ClinicalTrials.gov Identifier: NCT00273624     History of Changes
Other Study ID Numbers: Olanzapine Augmentation
Study First Received: January 4, 2006
Last Updated: February 17, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on November 25, 2014