A Study in the Treatment of Children and Adolescents With Major Depressive Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00849693
• Date of registration: 23/02/2009
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
• Scientific title: A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder
• Date of first enrolment: March 2009
• Target sample size: 463
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00849693
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Canada, Mexico, United States

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Outpatient, diagnosed with major depressive disorder (MDD) as defined by the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
(DSM-IV-TR) and supported by the Mini International Neuropsychiatric Interview for
children and adolescents (MINI-KID).

- Diagnosis of moderate or greater severity of MDD as determined by Children's
Depression Rating Scale - Revised (CDRS-R) with a total score greater than or equal to
40 at screen, and randomization and a Clinical Global Impression of Severity
(CGI-Severity) rating of greater than or equal to 4 at screen, and randomization.

- Female patients must test negative for pregnancy during screening.

- Judged to be reliable by the investigator to keep all appointments for clinical
visits, tests, and procedures required by the protocol.

- Has a degree of understanding such that they can communicate intelligently with the
investigator and study coordinator.

- Capable of swallowing study drug whole. It is anticipated the patients will need to
swallow up to 6 capsules per day.

- Patients must have venous access sufficient to allow blood sampling and are compliant
with blood draws as per the protocol.

Exclusion Criteria:

- Children of site personnel directly affiliated with this study and/or their immediate
families.

- Children of Lilly employees or employees of the designated clinical research
organization (CRO) assisting with the conduct of 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.

- Have a current or previous diagnosis of bipolar disorder, psychotic depression,
schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive
disorder, or pervasive development disorder, as judged by the investigator.

- Have a history of DSM-IV-TR-defined substance abuse or dependence within the past
year, excluding caffeine and nicotine.

- Have a current primary DSM-IV-TR Axis I disorder other than MDD or a current secondary
DSM-IV-TR Axis I disorder that requires any pharmacologic treatment

- Have 1 or more first-degree relatives with diagnosed bipolar I disorder.

- Have a significant suicide attempt within 1 year of screening or are currently at risk
of suicide in the opinion of the investigator.

- Have a weight less than 20 kilogram (kg) at screening.

- Have a lack of response to 2 or more adequate treatment trials of antidepressants at a
clinically appropriate dose for a minimum of 4 weeks for the same MDD episode.

- Have initiated, stopped, or changed the type or intensity of psychotherapy within 6
weeks prior to screening.

- Have a history of seizure disorder (other than febrile seizures).

- Have a history of electroconvulsive therapy within 1 year of screening.

- Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days or
fluoxetine within 30 days of randomization; or the potential need to use an MAOI
during the study or within 5 weeks of discontinuation of study drug.

- Have previously enrolled, completed, or withdrawn from this study or any other study
investigating duloxetine or fluoxetine.

- Have a positive urine drug screen for any substances of abuse or excluded medication.

- Are taking any excluded medications that cannot be discontinued by screening.

- Have known hypersensitivity to duloxetine, fluoxetine, or their inactive ingredients;
or have frequent or severe allergic reactions to multiple medications.

- Have uncontrolled narrow-angle glaucoma.

- Have acute liver injury or severe cirrhosis.

- Have a serious or unstable medical illness, psychological condition, or clinically
significant laboratory or electrocardiogram (ECG) result that, in the opinion of the
investigator, would compromise participation in the study or be likely to lead to
hospitalization.

- Have abnormal thyroid-stimulating hormone concentration.

- Have initiated or discontinued hormone therapy within the previous 3 months.

- Female patients who are either pregnant, nursing or have recently given birth.

- Need to use thioridazine during the study or within 5 weeks after discontinuation of
study drug or need to use pimozide during the study.



Age minimum: 7 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: fluoxetine

Drug: Placebo

Drug: duloxetine

Primary Outcome(s)

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint [Time Frame: Baseline, Week 10]

Secondary Outcome(s)

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint [Time Frame: Baseline, Week 10]

Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36 [Time Frame: Week 10 through Week 36]

Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36 [Time Frame: Week 10 through Week 36]

Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint [Time Frame: Baseline, Week 10]

Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10 [Time Frame: Baseline through Week 10]

Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint [Time Frame: Week 10, Week 36]

Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint [Time Frame: Week 10, Week 36]

Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint [Time Frame: Week 10, Week 36]

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint [Time Frame: Baseline, Week 10]

Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36 [Time Frame: Week 10 through Week 36]

Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10 [Time Frame: Baseline through Week 10]

Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10 [Time Frame: Baseline through Week 10]

Secondary ID(s)

F1J-MC-HMCL

7109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/04/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00849693