A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01687478
First received: September 7, 2012
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to assess the efficacy and safety of olanzapine and fluoxetine compared to placebo and fluoxetine as treatment for treatment-resistant depression (TRD) in Chinese participants.


Condition Intervention Phase
Treatment Resistant Depression
Drug: Olanzapine
Drug: Fluoxetine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Assess the Short-Term Efficacy and Safety of Olanzapine and Fluoxetine Compared to Placebo and Fluoxetine for Nonpsychotic Treatment-Resistant Depression

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean Change from Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, up to 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change from Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale [ Time Frame: Baseline, up to 8 Weeks ] [ Designated as safety issue: No ]
  • Mean Change from Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS) [ Time Frame: Baseline, up to 8 Weeks ] [ Designated as safety issue: Yes ]
  • Mean Change from Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36) [ Time Frame: Baseline, up to 8 Weeks ] [ Designated as safety issue: No ]
  • Mean Change from Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS) [ Time Frame: Baseline, up to 8 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants who Achieve a Response Based on a ≥50% Reduction from Baseline in MADRS Total Score [ Time Frame: Baseline up to 8 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks [ Time Frame: Baseline up to 8 Weeks ] [ Designated as safety issue: No ]
  • Mean Change from Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, up to 8 Weeks ] [ Designated as safety issue: Yes ]
  • Mean Change from Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, up to 8 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 229
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olanzapine + Fluoxetine

Olanzapine starting dose is 5 milligram (mg) (1 tablet). May titrate up to 10 mg (2 tablets), or 15 mg (3 tablets) administered once daily by mouth for 8 weeks.

Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.

Drug: Olanzapine
Administered Orally
Other Names:
  • LY170053
  • Zyprexa
Drug: Fluoxetine
Administered Orally
Other Names:
  • LY110140
  • Prozac
Placebo Comparator: Placebo + Fluoxetine

Placebo matches the Olanzapine tablet for blinding.

Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.

Drug: Fluoxetine
Administered Orally
Other Names:
  • LY110140
  • Prozac
Drug: Placebo
Administered Orally

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have single or recurrent unipolar major depressive disorder (MDD) without psychotic features by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) clinical assessment
  • Have a total score ≥22 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at screening and randomization
  • Have treatment-resistant depression (TRD), defined as having failed to achieve a satisfactory antidepressant response, in the opinion of the investigator, to separate treatment courses of at least 2 different antidepressants, other than fluoxetine, of adequate dosage and duration (≥6 weeks) within the current major depressive episode

Exclusion Criteria:

  • Have a diagnosis of Parkinson's disease or a related disorder
  • Have a current or lifetime diagnosis of any of the following conditions, according to DSM-IV-TR criteria: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder; Delusional Disorder; Psychotic Disorder Not Otherwise Specified; Bipolar Disorder I or II; Delirium of any type; Dementia of any type; Amnestic Disorder; any Substance-Induced Disorder; or any Psychotic Disorder due to a General Medical Condition
  • Have a current diagnosis of post-partum depression or MDD with a seasonal pattern as defined in the DSM-IV-TR
  • Have paranoid, schizoid, schizotypal, antisocial, or borderline personality disorder (Axis II) as a comorbid or primary diagnosis, based on DSM-IV-TR criteria
  • Have DSM-IV-TR substance dependence/abuse or are not willing to avoid use of the substance (not including dependence on nicotine or caffeine) within 30 days of screening
  • Are actively suicidal in the judgment of the investigator
  • Have uncorrected narrow-angle glaucoma
  • Have had one or more seizures without a clear and resolved etiology
  • Have leukopenia
  • Have any acute, serious, or unstable medical conditions
  • Have an increased serum prolactin concentration at screening
  • Have a rate-corrected cardiac QT interval, calculated using Bazett's formula (QTc Bazett's [QTcB]), on Electrocardiogram (ECG) >450 milliseconds (male) or >470 milliseconds (female) at screening
  • Have a history of allergic reaction to olanzapine, fluoxetine, or olanzapine in combination with fluoxetine
  • Have had treatment with olanzapine, fluoxetine, or olanzapine in combination with fluoxetine withdrawn due to clinically significant and/or intolerable adverse effects within 6 months of screening
  • Have received treatment with remoxipride within 6 months of randomization
  • Have received treatment with depot antipsychotics within one dosing interval before randomization
  • Have received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) treatment within the current MDD episode, or has a history of failure to respond to adequate treatment courses of ECT or VNS, or is expected to require ECT or VNS at any time during the study
  • Have received previous treatment with clozapine
  • Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of screening, or are expected to need MAOI treatment at any time during the study or up until 5 weeks after study discontinuation
  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: NCT01687478

Contacts
Contact: There maybe multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559

Locations
China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Baoding, China, 071000
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Beijing, China, 100088
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Changsha, China, 410011
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Guang Zhou, China, 560370
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Hangzhou, China, 310009
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Kunming, China, 650032
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Nanjing, China, 210029
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Shanghai, China, 200030
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Wu Han, China, 430022
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Xi'An, China, 710032
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Xinxiang, China, 453002
Contact: Eli Lilly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01687478     History of Changes
Other Study ID Numbers: 13702, F1D-CR-HGNB
Study First Received: September 7, 2012
Last Updated: July 11, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014