NCT00062673

Brief Summary

A study of the safety and efficacy of duloxetine in elderly patients (greater than 65 years old) with major depressive disorder

Trial Health

87
On Track

Trial Health Score

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

Enrollment
311

participants targeted

Target at P50-P75 for phase_3 depression

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_3 depression

Geographic Reach
1 country

1 active site

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

March 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

May 21, 2007

Status Verified

May 1, 2007

First QC Date

June 10, 2003

Last Update Submit

May 17, 2007

Conditions

DepressionCognition

Outcome Measures

Primary Outcomes (4)

  • To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Verbal Learning & Recall Test (VLRT)

  • To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Symbol Digit Substitution Test (SDST)

  • To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from 2-Digit Cancellation Test (2DCT)

  • To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Letter-Number Sequencing Test (LNST)

Secondary Outcomes (7)

  • To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the Geriatric Depression Scale (GDS)

  • To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the 17-item Hamilton Depression Rating Scale (HAMD17) total score

  • To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by response and remission rates

  • To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the Clinical Global Impressions of Severity Scale (CGI Severity) and the HAMD17 subscale scores

  • To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on the painful physical symptoms of depression, as measured by the Visual Analog Scale for pain (VAS)

  • +2 more secondary outcomes

Interventions

DuloxetineDRUG
PlaceboDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • You must be able to visit the doctor's office for clinic visits, tests, and procedures.
  • You must have been diagnosed with major depression, and have had at least one other episode in the past.

You may not qualify if:

  • You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
  • You have taken a drug within the last 30 days that has not been approved for use by governmental authorities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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.

Middleton, Wisconsin, United States

Location

Related Publications (6)

  • Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.

    PMID: 25080392DERIVED

  • Oakes TM, Katona C, Liu P, Robinson M, Raskin J, Greist JH. Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies. Int Clin Psychopharmacol. 2013 Jan;28(1):1-11. doi: 10.1097/YIC.0b013e32835b09cd.

    PMID: 23138680DERIVED

  • Raskin J, Wiltse CG, Dinkel JJ, Walker DJ, Desaiah D, Katona C. Safety and tolerability of duloxetine at 60 mg once daily in elderly patients with major depressive disorder. J Clin Psychopharmacol. 2008 Feb;28(1):32-8. doi: 10.1097/jcp.0b013e318160738e.

    PMID: 18204338DERIVED

  • Wise TN, Wiltse CG, Iosifescu DV, Sheridan M, Xu JY, Raskin J. The safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity. Int J Clin Pract. 2007 Aug;61(8):1283-93. doi: 10.1111/j.1742-1241.2007.01476.x. Epub 2007 Jun 22.

    PMID: 17590215DERIVED

  • Raskin J, Xu JY, Kajdasz DK. Time to response for duloxetine 60 mg once daily versus placebo in elderly patients with major depressive disorder. Int Psychogeriatr. 2008 Apr;20(2):309-27. doi: 10.1017/S1041610207005649. Epub 2007 Jun 22.

    PMID: 17588276DERIVED

  • Raskin J, Wiltse CG, Siegal A, Sheikh J, Xu J, Dinkel JJ, Rotz BT, Mohs RC. Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder: an 8-week, double-blind, placebo-controlled trial. Am J Psychiatry. 2007 Jun;164(6):900-9. doi: 10.1176/ajp.2007.164.6.900.

    PMID: 17541049DERIVED

Related Links

MeSH Terms

Conditions

Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 10, 2003

First Posted

June 12, 2003

Study Start

March 1, 2003

Study Completion

July 1, 2004

Last Updated

May 21, 2007

Record last verified: 2007-05

Locations

US(1)