NCT00810069|CompletedPhase 4Results

Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder

Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

12329F1J-EW-HMGD

Study Type

interventional

Target

840

Locations

11 countries

Sites

Timeline

RegisteredDec 2008

StartedNov 2008

CompletionMar 2010

Brief Summary

This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention. Two hypothesis will be tested:

1.that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
2.that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.

Trial Health

On Track

Trial Health Score

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

Enrollment

840

participants targeted

Target at P75+ for phase_4 major-depressive-disorder

Timeline

Completed

Started Nov 2008

Shorter than P25 for phase_4 major-depressive-disorder

Geographic Reach

11 countries

60 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

1.3 years study duration

Study Start

First participant enrolled

November 1, 2008

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

June 21, 2011

Completed

Last Updated

June 21, 2011

Status Verified

May 1, 2011

Enrollment Period

1.3 years

First QC Date

December 16, 2008

Results QC Date

February 4, 2011

Last Update Submit

May 20, 2011

Conditions

Major Depressive Disorder

Keywords

Major Depressive DisorderMDDDepression

Outcome Measures

Primary Outcomes (4)

Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Week 4 through Week 16
Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response
Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as \>=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Week 4 through Week 16
Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Week 4 through Week 16
Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission
Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Week 4 through Week 16

Secondary Outcomes (14)

Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits
Week 4 through Week 16
Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.
Week 4 through Week 16
Clinical Global Impressions of Severity (CGI-S) Scale
Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
Visual Analog Scale (VAS) - Overall Pain Severity
Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
Baseline, Week 4, Week 8, Week 12, Week 16
+9 more secondary outcomes

Study Arms (2)

Early Intervention

EXPERIMENTAL

Escitalopram 10 milligrams per day for 4 weeks (one 10 milligram \[mg\]-capsule) followed by Duloxetine flexible dose (60 or 120 mg daily) for 12 weeks.

Drug: Duloxetine HydrochlorideDrug: Escitalopram

Delayed Intervention

EXPERIMENTAL

Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule) followed by Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule\[s\]). Then, non-responders switched to Duloxetine 60 or 120 mg per day for 8 weeks , and responders continued on Escitalopram 10 to 20 mg per day for 8 weeks.

Drug: Duloxetine HydrochlorideDrug: Escitalopram

Interventions

Duloxetine HydrochlorideDRUG

Flexible dose of 60 or 120 mg daily

Also known as: Cymbalta, LY248686

Delayed InterventionEarly Intervention

EscitalopramDRUG

10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.

Also known as: Lexapro, Cipralex

Delayed InterventionEarly Intervention

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female participants of at least 18 years of age who meet criteria for Major Depressive Disorder (MDD), single or recurrent episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV®-TR) disease diagnostic criteria.
Participants (receiving or not antidepressant treatment) who, based on investigator criteria, initiate treatment with escitalopram or change their current Alzheimer's Disease (AD) treatment to escitalopram for this current MDD episode, at the initial visit.
Must have a baseline score of ≥ 19 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at the initial visit.
Must have a baseline score of ≥ 4 in the Clinical Global Impression-Severity Scale (CGI-S) at the initial visit.
Have a level of understanding sufficient to provide Informed Consent Document (ICD), and to communicate with the investigators and site personnel.
Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.

You may not qualify if:

Have any current primary Axis I disorder other than MDD, including but not limited to dysthymia.
Have a diagnosis of dementia, Alzheimer's disease (AD), or organic brain syndrome; or who are cognitively impaired or who have language problems that prevent them from understanding and/or providing valid answers to the rating scale contents.
Concomitant participation in other studies with investigational or marketed products.
Are not expected to be able to be monitored throughout the entire study period for reasons unrelated to their illness (for instance, change of residence or healthcare center of reference).
Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit.
Are investigator site personnel directly affiliated with this study and/or their immediate families. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Are employed by Lilly or Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or BI employees may participate in Lilly or BI-sponsored clinical trials, but are not permitted to participate at a Lilly or BI facility. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Women of childbearing potential who are not using a medically accepted means of contraception (for example, intrauterine device, oral contraceptive, contraceptive patch, implant, Depo-Provera \[medroxyprogesterone acetate injectable suspension, Pharmacia \& Upjohn\], or barrier devices) when engaging in sexual intercourse. Women who are pregnant or breast-feeding may not participate in the study.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Are judged to be at serious suicidal risk in the opinion of the investigator, and/or if the participant's baseline (Visit 1) HAMD-17 scores on item 3 suicide are 3.
Have been treated with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1 or potential need to use an MAOI during the study or within 5 days after discontinuation of study drug.
Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment (Visit 1) or at any time during the study.
Have any contraindication for the use of duloxetine based on Duloxetine Summary of Product Characteristics (SPC) or any contraindication for the use of escitalopram based on Escitalopram SPC.
Have a history of lack of response to duloxetine or escitalopram at a clinically appropriate dose for a minimum of 4 weeks, or have previously completed or withdrawn from this study or any other study investigating duloxetine or escitalopram.
Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (60)

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

Copenhagen, DK-2100, Denmark

Location

Angoulême, 16000, France

Location

Arcachon, 33120, France

Location

Dole, 39100, France

Location

Gujan-Mestras, 33470, France

Location

Marseille, 13385, France

Location

Montpellier, F-34295, France

Location

Nîmes, 30029, France

Location

Orvault, 44000, France

Location

Rennes, 35000, France

Location

Athens, 10675, Greece

Location

Haidari, Athens, 12462, Greece

Location

Thessaloniki, 56429, Greece

Location

Tripoli, 22100, Greece

Location

Balassagyarmat, 2660, Hungary

Location

Budapest, 1134, Hungary

Location

Chieti, 66100, Italy

Location

Foggia, 71100, Italy

Location

Milan, 20121, Italy

Location

Modena, 41100, Italy

Location

Parma, 43100, Italy

Location

Pisa, 56100, Italy

Location

Siena, 53100, Italy

Location

Teramo, 64100, Italy

Location

Terracina, 04019, Italy

Location

Torino, 10126, Italy

Location

Beek en Donk, 5741 CG, Netherlands

Location

Brummen, 6971 AD, Netherlands

Location

Brunssum, 6442 AG, Netherlands

Location

Deurne, 5751 XJ, Netherlands

Location

Heerde, 8181 TB, Netherlands

Location

Bucharest, 020125, Romania

Location

Constanța, Romania

Location

Iași, 700282, Romania

Location

Timișoara, 300182, Romania

Location

Ljubljana, 1000, Slovenia

Location

Alcalá de Henares, 28806, Spain

Location

Barcelona, 08025, Spain

Location

Ferrol, 15405, Spain

Location

Foios, 46134, Spain

Location

Madrid, 28029, Spain

Location

Palma de Mallorca, 07013, Spain

Location

Salamanca, 37003, Spain

Location

Seville, 41700, Spain

Location

Vigo, 36205, Spain

Location

Zamora, 49021, Spain

Location

Zaragoza, 50002, Spain

Location

Gothenburg, 41345, Sweden

Location

Halmstad, 302 32, Sweden

Location

Luleå, SE 972 35, Sweden

Location

Lund, 223 61, Sweden

Location

Malmo, 21135, Sweden

Location

Stockholm, 11486, Sweden

Location

Sundsvall, SE-85231, Sweden

Location

Ankara, 06000, Turkey (Türkiye)

Location

Antakya, 31040, Turkey (Türkiye)

Location

Çapa, 34390, Turkey (Türkiye)

Location

Dışkapı, 06110, Turkey (Türkiye)

Location

Izmir, 35340, Turkey (Türkiye)

Location

Şişli, 80220, Turkey (Türkiye)

Location

Related Publications (1)

Romera I, Perez V, Menchon JM, Schacht A, Papen R, Neuhauser D, Abbar M, Svanborg P, Gilaberte I. Early switch strategy in patients with major depressive disorder: a double-blind, randomized study. J Clin Psychopharmacol. 2012 Aug;32(4):479-86. doi: 10.1097/JCP.0b013e31825d9958.
PMID: 22722513DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Duloxetine HydrochlorideEscitalopramDexetimide

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperidonesPiperidines

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM 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 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

November 1, 2008

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

June 21, 2011

Results First Posted

June 21, 2011

Record last verified: 2011-05

Locations

NL(5)HU(2)SL(1)IT(10)ES(11)SE(7)FR(9)TU(6)DK(1)RO(4)GR(4)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (14)

Study Arms (2)

Early Intervention

Delayed Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (60)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations