Trial · NCT02431806

Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

NCT02431806, Phase 3, Completed, Forest Laboratories; results first posted 2020-09-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder. Trials, record NCT02431806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02431806

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder
NCT number: NCT02431806
Status: Completed
Phases: Phase 3
Enrollment: 552 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Major Depressive Disorder
Interventions: Placebo, Levomilnacipran, Fluoxetine
First posted: 2015-05-01
Last updated: 2020-09-07
Results first posted: 2020-09-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score	Baseline (Week 0) to Week 8	CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.
Secondary	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Baseline (Week 0) to Week 8	The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score	Baseline (Week 0) to Week 8	ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Baseline (Week 0) to Week 8	ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score. Overall number of participants analyzed is the number of participants with data available for analyses.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score	Placebo	-22.90	Standard Error 1.09	score on a scale
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score	Levomilnacipran 40 mg/Day	-23.28	Standard Error 1.11	score on a scale
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score	Levomilnacipran 80 mg/Day	-22.64	Standard Error 1.12	score on a scale
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score	Fluoxetine 20 mg/Day	-24.37	Standard Error 1.12	score on a scale
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Placebo	-1.54	Standard Error 0.10	score on a scale
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Levomilnacipran 40 mg/Day	-1.52	Standard Error 0.10	score on a scale
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Levomilnacipran 80 mg/Day	-1.52	Standard Error 0.10	score on a scale
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Fluoxetine 20 mg/Day	-1.68	Standard Error 0.10	score on a scale

Source ClinicalTrials.gov

Participant flow28

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-blind Treatment Period	STARTED	Placebo	142
Double-blind Treatment Period	STARTED	Levomilnacipran 40 mg/Day	136
Double-blind Treatment Period	STARTED	Levomilnacipran 80 mg/Day	139
Double-blind Treatment Period	STARTED	Fluoxetine 20 mg/Day	135
Double-blind Treatment Period	Safety Population	Placebo	141
Double-blind Treatment Period	Safety Population	Levomilnacipran 40 mg/Day	134
Double-blind Treatment Period	Safety Population	Levomilnacipran 80 mg/Day	138
Double-blind Treatment Period	Safety Population	Fluoxetine 20 mg/Day	134
Double-blind Treatment Period	COMPLETED	Placebo	117
Double-blind Treatment Period	COMPLETED	Levomilnacipran 40 mg/Day	115

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Tachycardia	Cardiac disorders	Placebo	1	141
other	Tachycardia	Cardiac disorders	Levomilnacipran 40 mg/Day	13	134
other	Tachycardia	Cardiac disorders	Levomilnacipran 80 mg/Day	12	138
other	Tachycardia	Cardiac disorders	Fluoxetine 20 mg/Day	5	134
other	Nausea	Gastrointestinal disorders	Placebo	8	141
other	Nausea	Gastrointestinal disorders	Levomilnacipran 40 mg/Day	19	134
other	Nausea	Gastrointestinal disorders	Levomilnacipran 80 mg/Day	22	138
other	Nausea	Gastrointestinal disorders	Fluoxetine 20 mg/Day	5	134
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	4	141
other	Abdominal pain upper	Gastrointestinal disorders	Levomilnacipran 40 mg/Day	6	134

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	141
Total, all-cause mortality	Levomilnacipran 40 mg/Day	0	134
Total, all-cause mortality	Levomilnacipran 80 mg/Day	0	138
Total, all-cause mortality	Fluoxetine 20 mg/Day	0	134
Total, other adverse events	Placebo	33	141
Total, other adverse events	Levomilnacipran 40 mg/Day	54	134
Total, other adverse events	Levomilnacipran 80 mg/Day	63	138
Total, other adverse events	Fluoxetine 20 mg/Day	41	134
Total, serious adverse events	Placebo	0	141
Total, serious adverse events	Levomilnacipran 40 mg/Day	2	134

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38700708	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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