Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00529789

First received: September 12, 2007

Last updated: October 18, 2011

Last verified: October 2011

History of Changes

Results First Received: September 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Major Depressive Disorder
Intervention:	Drug: duloxetine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Period I was a 2-week Screening/Washout Phase. Period II was a 10-week Dose-Titrating with Pharmacokinetic Sampling Phase. Period III was an 8-week Safety and Tolerability Phase. Period IV was a 3-month Extended Safety and Tolerability Phase. Period V was a 2-week Taper Phase. Results presented are for combined Periods II/III and Period IV.

Reporting Groups

	Description
Duloxetine	20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.

Participant Flow for 2 periods

Period 1: Study Period II/III

	Duloxetine
STARTED	72
COMPLETED	48
NOT COMPLETED	24
Parent/Caregiver Decision	9
Adverse Event	3
Lack of Efficacy	2
Withdrawal by Subject	1
Protocol Violation	3
Physician Decision	3
Lost to Follow-up	3

Period 2: Study Period IV

	Duloxetine
STARTED	48
COMPLETED	42 ^[1]
NOT COMPLETED	6
Parent/Caregiver Decision	1
Adverse Event	1
Lack of Efficacy	1
Lost to Follow-up	3

[1]	Includes 1 patient who withdrew at last visit; didn't enter Taper; however received 30 weeks of drug

Baseline Characteristics

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Reporting Groups

	Description
Duloxetine	20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.

Baseline Measures

	Duloxetine
Number of Participants [units: participants]	72
Age [units: years] Mean ± Standard Deviation	12.5 ± 2.9
Gender [units: participants]
Female	35
Male	37
Region of Enrollment [units: participants]
United States	72
Race/Ethnicity [units: participants]
African	17
Caucasian	42
East Asian	1
Hispanic	11
Native American	1
Tobacco Use ^[1] [units: participants]
No	70
Yes	1
Not Available	1
Body Mass Index (BMI) ^[2] [units: kilograms/square meters (kg/m^2)] Mean ± Standard Deviation	23.7 ± 6.4

[1]	Tobacco use was based on cotinine level.
[2]	Body mass index is an estimate of body fat based on body weight divided by height squared.

Outcome Measures

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1. Primary:

Number of Participants With Emergence of Suicidal Ideation During Period II/III [ Time Frame: Baseline to 18 weeks ]

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2. Primary:

Number of Participants With Emergence of Suicidal Ideation During Period IV [ Time Frame: Week 0 and Between 18 and 30 Weeks ]

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3. Primary:

Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III [ Time Frame: Baseline to 18 Weeks ]

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4. Primary:

Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV [ Time Frame: Between 18 and 30 Weeks ]

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5. Primary:

Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III [ Time Frame: Baseline to 18 Weeks ]

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6. Primary:

Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV [ Time Frame: Between 18 and 30 Weeks ]

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7. Primary:

Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III [ Time Frame: Baseline to 18 Weeks ]

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8. Primary:

Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV [ Time Frame: Between 18 and 30 Weeks ]

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9. Primary:

Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III [ Time Frame: Baseline to 18 Weeks ]

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10. Primary:

Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV [ Time Frame: Between 18 and 30 Weeks ]

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11. Secondary:

Pharmacokinetics: Summary of Observed Duloxetine Plasma Concentrations Stratified by Duloxetine Dose [ Time Frame: Weeks 2, 4, 6, 8, 10, 14, 18 ]

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12. Secondary:

Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S) [ Time Frame: Week 0 (Baseline), 18 Weeks, 30 Weeks ]

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13. Secondary:

Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score [ Time Frame: Week 0 (Baseline), 18 Weeks, 30 Weeks ]

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14. Other Pre-specified:

Adverse Events Leading to Discontinuation [ Time Frame: Week 0 (Baseline) to 30 Weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The Results Record was revised as a result of correcting identified errors in the number of participants with potentially significant changes in blood pressure.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00529789 History of Changes
Other Study ID Numbers:	11664, F1J-MC-HMFN
Study First Received:	September 12, 2007
Results First Received:	September 22, 2009
Last Updated:	October 18, 2011
Health Authority:	United States: Food and Drug Administration

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