NCT00958568

Brief Summary

The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant Depression stable, determine if OFC is safe when used to treat patients with Treatment Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression when treated for a long time (up to 47 weeks) and to assess the quality of life during treatment.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
892

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2009

Typical duration for phase_3

Geographic Reach
8 countries

66 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 1, 2014

Completed
Last Updated

April 1, 2014

Status Verified

February 1, 2014

Enrollment Period

2.6 years

First QC Date

August 12, 2009

Results QC Date

March 22, 2013

Last Update Submit

February 17, 2014

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

  • Time to Relapse by Any Criteria

    Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation.

    Randomization (Week 20) to Week 47

Secondary Outcomes (37)

  • Percentage of Participants Who Relapse by Any Criteria

    Randomization (Week 20) to Week 47

  • Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score

    Randomization (Week 20) to Week 47

  • Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality

    Randomization (Week 20) to Week 47

  • Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality

    Randomization (Week 20) to Week 47

  • Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score

    Randomization (Week 20) to Week 47

  • +32 more secondary outcomes

Other Outcomes (1)

  • Kaplan-Meier Estimate of Percentage of Subjects Not Relapsing at Week 27 (Day 189)

    Randomization (Week 20) to Week 27

Study Arms (2)

Olanzapine and Fluoxetine combination (OFC)

EXPERIMENTAL
Drug: Olanzapine and Fluoxetine combination (OFC)

Fluoxetine

ACTIVE COMPARATOR
Drug: Fluoxetine

Interventions

Olanzapine and Fluoxetine combination (OFC)DRUG

Open label acute phase: introductory dose for 4 days then 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks. Open label stabilization phase: 6/25, 12/25, 6/50, 12/50 or 18/50 mg, oral, daily for 16-20 weeks. Double blind relapse prevention phase: dose determined during stabilization phase at Week 17, oral, daily, for 27 weeks.

Also known as: Symbyax, LY900000
Olanzapine and Fluoxetine combination (OFC)
FluoxetineDRUG

25 or 50 mg/day fixed dosing for 27 weeks

Also known as: Prozac, LY1101440
Fluoxetine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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, confirmed by the structured clinician Interview for DSM-IV Axis 1 disorders (SCID-I).
  • If female and of childbearing potential, test negative for pregnancy and agree to abstain from sexual activity or use a medically accepted means of contraception during the study. Use of any oral or injectable contraception must be initiated prior to receiving treatment.
  • Have 17-item Hamilton Depression (HAM-D) score greater than or equal to 18 at screening and the day treatment is due to be received for the first time.
  • Have treatment-resistant depression, as defined by having demonstrated failure to achieve satisfactory antidepressant response to adequate separate treatment courses of at least 2 different antidepressants within the current episode of MDD.

You may not qualify if:

  • Have a diagnosis of Parkinson's disease or related disorders.
  • Have a current or lifetime diagnosis of any of the following according to DSM-IV 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 current diagnosis of post-partum depression, MDD with atypical features, or MDD with a seasonal pattern as defined in the DSM-IV.
  • Have paranoid, schizoid, schizotypal, antisocial, and borderline personality disorders (Axis II) as a comorbid or primary diagnosis, based on DSM-IV criteria.
  • Have had psychotic symptoms within 1 month prior to Screening or demonstrate psychotic features at screening and on the day treatment is due to be assigned for the first time as determined by the investigator.
  • Have DSM-IV substance dependence/abuse or not willing to avoid use of the substance (not including dependence on nicotine or caffeine), as defined by the SCID-I, within the past 30 days.
  • Are actively suicidal in the judgment of the investigator.
  • Have had one or more seizures without a clear and resolved etiology.
  • Have leukopenia or history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the participant's lifetime.
  • Have alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) values greater than or equal to 2 times the ULN or total bilirubin values greater than or equal to 1.5 times the ULN at any time during screening.
  • Have acute, serious, or unstable medical conditions.
  • Have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 6 months.
  • Have elevated prolactin levels at screening.
  • Have Bazett's corrected QT interval (QTc) greater than 450 milliseconds (male) or greater than 470 milliseconds (female) at screening and when treatment is due to be received for the first time.
  • Have received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) treatment within the current episode; have a history of failure to adequate treatment courses of ECT or VNS; or will require ECT or VNS at any time during study participation.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (66)

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Pasadena, California, 91106, United States

Location

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Sherman Oaks, California, 91403, United States

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Wildomar, California, 92595, United States

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Cromwell, Connecticut, 06416, United States

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Washington D.C., District of Columbia, 20016, United States

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Atlanta, Georgia, 30308, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60640, United States

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Oak Brook, Illinois, 60523, United States

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Lafayette, Indiana, 47905, United States

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Florence, Kentucky, 41042, United States

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Baltimore, Maryland, 21285, United States

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Glen Burnie, Maryland, 21061, United States

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Belmont, Massachusetts, 02478, United States

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Boston, Massachusetts, 02135, United States

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Bridgeton, Missouri, 63044, United States

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Saint Charles, Missouri, 63301, United States

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St Louis, Missouri, 63141, United States

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Nashua, New Hampshire, 03060, United States

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Cherry Hill, New Jersey, 08002, United States

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Brooklyn, New York, 11235, United States

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Cedarhurst, New York, 11516, United States

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Mount Kisco, New York, 10549, United States

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Staten Island, New York, 10312, United States

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Beachwood, Ohio, 44122, United States

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Allentown, Pennsylvania, 18103, United States

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Media, Pennsylvania, 19063, United States

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Philadelphia, Pennsylvania, 19139, United States

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Austin, Texas, 78731, United States

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Woodstock, Vermont, 05091, United States

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Bellevue, Washington, 98004, United States

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Seattle, Washington, 98104, United States

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Spokane, Washington, 99204, United States

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Brown Deer, Wisconsin, 53223, United States

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Middleton, Wisconsin, 53562, United States

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West Allis, Wisconsin, 53227, United States

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Banfield, B1828CKR, Argentina

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Buenos Aires, C1122AAN, Argentina

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La Plata, 1900, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Ahmedabad, 380013, India

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Bangalore, 560010, India

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Chennai, 600003, India

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Hyderabaad, 500034, India

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Ludhiana, 141001, India

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Mysore, 570004, India

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Raipur, 492001, India

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Col. Florida, 01030, Mexico

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Mexico City, 14330, Mexico

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Monterrey, 64640, Mexico

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Ponce, 00731-7779, Puerto Rico

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Khot'kovo, 127025, Russia

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Nizhny Novgorod, 603155, Russia

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Saint Petersburg, 192019, Russia

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Village Nikolskoe, 188357, Russia

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Bellville, 7530, South Africa

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Centurion, 0046, South Africa

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George, 6530, South Africa

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Kempton Park, 1619, South Africa

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Antalya, 07070, Turkey (Türkiye)

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Elâzığ, 23800, Turkey (Türkiye)

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Gaziantep, Turkey (Türkiye)

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Istanbul, 34303, Turkey (Türkiye)

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Istanbul, 34736, Turkey (Türkiye)

Location

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Mersin, 33079, Turkey (Türkiye)

Location

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Şişli, 80220, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

olanzapine-fluoxetine combinationFluoxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 1, 2014

Results First Posted

April 1, 2014

Record last verified: 2014-02

Locations

ZA(4)AR(4)RU(4)PR(1)TU(7)IN(7)US(36)ME(3)