Major Depressive DisorderPhase 3NCT03569475

Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder

A Phase 3 study testing Levomilnacipran ER and Fluoxetine in people with Major Depressive Disorder, run by Allergan at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD). Read more about this study

Who is it for?: Ages 7 to 17 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Levomilnacipran ER and Fluoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 501 participants
Where: 51 sitesUnited States
Study dates: 6 Jul 2018to 1 Mar 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients must meet Diagnostic and statistical manual of mental disorders fifth edition (DSM-5) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders - Present and Lifetime (K-SADS-PL)
Patients must have a score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
Patients must have a Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
Patients must have a caregiver who can and is willing to consent to be responsible for safety monitoring of the Patient, provide information about the patient's condition, oversee the administration of investigational product, and accompany the patients to all study visits
Female patients of childbearing potential who are sexually active must agree to use a reliable method of contraception that will continue for the duration of the study and within 30 days following the end of study participation.
A sexually active male patients must agree to use contraception as detailed below during the treatment period and for at least 30 days after the last dose of investigational product.

Who cannot join

DSM-5-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment.
Prior diagnosis of mental retardation or amnestic or other cognitive disorders based on DSM-5 criteria
Imminent risk of injuring self or others or causing damage to property as judged by the Investigator
Suicide risk as determined by meeting either of the following criteria:
Any suicide attempt within the past year
Significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS) treatment-Related Criteria

Show all 22Show fewer

History of allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other Selective serotonin reuptake inhibitors (SSRI) or Serotonin and norepinephrine reuptake inhibitors (SNRI) or known hypersensitivity to the investigational products' non-medicinal ingredients including gelatin and cellulose
Patients requiring prohibited concomitant medication or herbal supplements that could not be discontinued or switched to an allowable alternative medication and stabilized for at least 2 weeks preceding Visit 2 (Baseline)
Patients taking any psychoactive drug or psychoactive herbal remedy within 5 half-lives before Baseline (Visit 2), Patients who have ever been treated with a depot antipsychotic must also be excluded
Patients who have initiated or terminated psychotherapy or behavior therapy within1 month before Visit 1 (Screening), or who plan to initiate or change such therapies during the course of the study Other Medical criteria
A clinically significant disease state that, in the investigator's opinion, might indicate that the patients is unsuitable for the study
Any cardiovascular disease or condition that is clinically significant, unstable, or decompensated.
Hypo- or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least 3 months before Visit 1 (Screening)
Any condition that would be expected to affect drug absorption (eg, gastric bypass surgery)
History of seizure disorder (except simple childhood febrile seizures before age 5), unexplained syncope or black-out episodes, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes the patient toward a risk for seizure
History of drug or alcohol abuse or dependence within the past year
Pregnant, breastfeeding, and/or planning to become pregnant and/or breastfeed during the study or within 30 days following the end of study participation
Patients who are unable to swallow capsules
Treatment with any investigational product within 3 months (or at least 5 half-lives, whichever is longer) of Visit 1. Treatment with any investigational product other than those provided by AGN during study participation will be a protocol violation, and the patient will be terminated from this study
Employee or immediate relative of an employee of Allergan (AGN), any of its affiliates or partners, or of the study center
Patients or patients whose parent/guardian/ legally authorized representative (LAR) and/or caregivers are unable to speak and understand English (or their native language if this can be accommodated by the site and is approved by the Sponsor) sufficiently to understand the nature of the study, to provide informed assent/consent, or to allow the completion of all study assessments
Unable or unlikely to comply with the study protocol or are unsuitable for any other reason, Other Criteriaas judged by the Investigator

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Atlanta Behavioral Research, LLC
Atlanta, Georgia, 30338
BioBehavioral Research of Austin
Austin, Texas, 78759
Houston Clinical Trials, LLC
Bellaire, Texas, 77401
Northwest Clinical Research Center
Bellevue, Washington, 98007
Care Access Research, Beverly Hills
Beverly Hills, California, 90212
University of Cincinnati
Cincinnati, Ohio, 45219
The Ohio State University Department of Psychiatry
Columbus, Ohio, 43210
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879
Millennium Center for Clinical Research
Creve Coeur, Missouri, 63141
Roque Medical Trails LLC
Dallas, Texas, 75243
iResearch Atlanta
Decatur, Georgia, 30030
El Campo Clinical Trials
El Campo, Texas, 77437
Mech Healthcare Associates
Frisco, Texas, 75034
Behavioral Research Specialists, LLC
Glendale, California, 91206
Advanced Research Institute of Miami
Homestead, Florida, 33030
Biopharma Informatic, LLC
Houston, Texas, 77084
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Sun Valley Research Center
Imperial, California, 92251
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, 70629
Zynak Clinical
Lauderdale Lakes, Florida, 33313
Northpointe Psychiatry
Lewisville, Texas, 75057
Capstone Clinical Research
Libertyville, Illinois, 60048
Alivation Research
Lincoln, Nebraska, 68526
Woodland International Research Group
Little Rock, Arkansas, 72211
Alliance Research
Long Beach, California, 90807
Professional Psychiatric Services
Mason, Ohio, 45040
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069
Advanced Clinical Research
Meridian, Idaho, 83642
Columbus Clinical Services, LLC
Miami, Florida, 33125
AMR Conventions Limited
Naperville, Illinois, 60563
AMR-Baber Research, Inc.
Naperville, Illinois, 60563
Manhattan Behavioral Medicine, PLLC
New York, New York, 10036
Excell Research, Inc.
Oceanside, California, 92056
IPS Research
Oklahoma City, Oklahoma, 73106
NRC Research Institute
Orange, California, 92868
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
AIM Trials
Plano, Texas, 75093
Finger Lake Clinical Research
Rochester, New York, 14618-1609
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, 78229
Attalla Consultants, LLC
Smyrna, Georgia, 30082
Millennium Psychiatric Associates, LLC
St Louis, Missouri, 63132
Clinical Research Institute
Stockbridge, Georgia, 30281
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381
Inova Clinical trials and Research Center
Tyrone, Georgia, 30290
Children's National Health System
Washington D.C., District of Columbia, 20910
CincyScience
West Chester, Ohio, 45069
KU Wichita Clinical Trial Unit
Wichita, Kansas, 67214
Elite Clinical Trials, Inc.
Wildomar, California, 92595

Other trials in United States

About this study

Official title: A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder

The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).

Conditions: Major Depressive Disorder
Being tested: Levomilnacipran ER, Fluoxetine, Placebo
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Levomilnacipran ERDrug
Levomilnacipran extended-release oral capsules
FluoxetineDrug
Fluoxetine oral capsules
PlaceboDrug
Matching placebo oral capsules

Study groups in NCT03569475
Study group	Role	What they receive
Levomilnacipran ER 40-80 mg/day	Experimental	Levomilnacipran extended release (ER) capsules, orally, 10 milligram per day (mg/day) on Days 1 to 3, 20 mg/day on Days 4 to 7, and 40 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by levomilnacipran ER 40 mg/day on Days 1 and 2, and then 20 mg/day from Day 3 through Day 7 in the Down-taper Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period. Receives: Drug: Levomilnacipran ER
Fluoxetine 20 mg/day	Active comparator	Fluoxetine capsule, orally, 10 mg/day at Week 1, and 20 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by fluoxetine 10 mg/day from Day 1 through Day 7 of the Down-taper Period. Receives: Drug: Fluoxetine
Placebo	Placebo comparator	Matching placebo capsules once daily through 8 weeks in the Double-blind Treatment Period and Days 1 through 7 in the Down-taper Period. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Children's Depression Rating Scale- Revised (CDRS-R)
The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years. It contains 17 ordinally-scaled items that evaluate the 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.
Measured: Baseline (Week 0) to Week 8

Secondary outcomes (1)

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.
Measured: Baseline (Week 0) to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 20181 Mar 2021

First posted26 Jun 2018
Study start6 Jul 2018
Primary completion1 Mar 2021
Study completion1 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 501 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03569475
Sponsor's protocol ID: LVM-MD-14
Status last verified: Mar 2022
First submitted: 15 Jun 2018
Last updated: 25 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

Radecki DT, Robieson WZ, Gopalkrishnan M, Greenberg E, Aziz M. Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies. J Child Adolesc Psychopharmacol. 2024 Jun;34(5):241-250. doi: 10.1089/cap.2023.0080. Epub 2024 May 3.
PubMed 38700708

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder
ClinicalTrials.gov ID: NCT03569475
Acronym / sponsor ID: LVM-MD-14
Conditions: Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 501 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 6 Jul 2018 (actual)
Primary completion: 1 Mar 2021 (actual)
Study completion: 1 Mar 2021 (actual)
First posted: 26 Jun 2018 (actual)
Results: Posted 25 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Levomilnacipran ER 40-80 mg/day	Experimental	Drug: Levomilnacipran ERLevomilnacipran extended release (ER) capsules, orally, 10 milligram per day (mg/day) on Days 1 to 3, 20 mg/day on Days 4 to 7, and 40 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by levomilnacipran ER 40 mg/day on Days 1 and 2, and then 20 mg/day from Day 3 through Day 7 in the Down-taper Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period.
Fluoxetine 20 mg/day	Active comparator	Drug: FluoxetineFluoxetine capsule, orally, 10 mg/day at Week 1, and 20 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by fluoxetine 10 mg/day from Day 1 through Day 7 of the Down-taper Period.
Placebo	Placebo comparator	Drug: PlaceboMatching placebo capsules once daily through 8 weeks in the Double-blind Treatment Period and Days 1 through 7 in the Down-taper Period.

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Patients must meet Diagnostic and statistical manual of mental disorders fifth edition (DSM-5) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders - Present and Lifetime (K-SADS-PL)
Patients must have a score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
Patients must have a Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
Patients must have a caregiver who can and is willing to consent to be responsible for safety monitoring of the Patient, provide information about the patient's condition, oversee the administration of investigational product, and accompany the patients to all study visits
Female patients of childbearing potential who are sexually active must agree to use a reliable method of contraception that will continue for the duration of the study and within 30 days following the end of study participation.

Key exclusion criteria (22 listed)

DSM-5-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment.
Prior diagnosis of mental retardation or amnestic or other cognitive disorders based on DSM-5 criteria
Imminent risk of injuring self or others or causing damage to property as judged by the Investigator
Suicide risk as determined by meeting either of the following criteria:
History of allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other Selective serotonin reuptake inhibitors (SSRI) or Serotonin and norepinephrine reuptake inhibitors (SNRI) or known hypersensitivity to the investigational products' non-medicinal ingredients including gelatin and cellulose

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Levomilnacipran ERLevomilnacipran extended-release oral capsules	Drug	Levomilnacipran ER 40-80 mg/day
FluoxetineFluoxetine oral capsules	Drug	Fluoxetine 20 mg/day
PlaceboMatching placebo oral capsules	Drug	Placebo

Primary outcome

Change From Baseline in Children's Depression Rating Scale- Revised (CDRS-R)
Time frame: Baseline (Week 0) to Week 8
The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years. It contains 17 ordinally-scaled items that evaluate the 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.

1 secondary outcome

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
Time frame: Baseline (Week 0) to Week 8

Results and safety

Results posted to the registry on 25 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	164	146
Levomilnacipran ER 40-80 mg/Day	169	146
Fluoxetine 20 mg/Day	168	144

Primary outcome: Change From Baseline in Children's Depression Rating Scale- Revised (CDRS-R)

Time frame: Baseline (Week 0) to Week 8. Least squares mean (Standard Error). Unit: score on a scale

Measure	Placebo n = 146	Levomilnacipran ER 40-80 mg/Day n = 148	Fluoxetine 20 mg/Day n = 144
Value	-21.3 (1.01)	-23.0 (1.01)	-23.1 (1.01)

Placebo vs Levomilnacipran ER 40-80 mg/Day: Least Square Mean Difference: -1.7 (95% CI -4.49 to 1.04), p = 0.2215, Mixed Model for Repeated Measures
Placebo vs Fluoxetine 20 mg/Day: Least Square Mean Difference: -1.8 (95% CI -4.59 to 0.95), p = 0.1964, Mixed Model for Repeated Measures

Population analysed: 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 are the number of participants with data available for analyses.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to approximately 9 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Double-blind Treatment Period)	1 of 160 (0.6%)	32 of 160 (20%)	0 of 164
Levomilnacipran ER 40-80 mg/Day (Double-blind Treatment Period)	1 of 166 (0.6%)	44 of 166 (26.5%)	0 of 169
Fluoxetine 20 mg/Day (Double-blind Treatment Period)	4 of 166 (2.4%)	37 of 166 (22.3%)	0 of 168
Placebo (Down-taper Period)	1 of 160 (0.6%)	3 of 160 (1.9%)	0 of 160
Levomilnacipran ER 40-80 mg/Day (Down-taper Period)	0 of 166 (0%)	3 of 166 (1.8%)	0 of 166
Fluoxetine 20 mg/Day (Down-taper Period)	0 of 166 (0%)	1 of 166 (0.6%)	0 of 166

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38700708Radecki DT, Robieson WZ, Gopalkrishnan M, Greenberg E, Aziz M. Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies. J Child Adolesc Psychopharmacol. 2024 Jun;34(5):241-250. doi: 10.1089/cap.2023.0080. Epub 2024 May 3.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Related trials for Major Depressive Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Radecki, PhD study director

Allergan

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levomilnacipran ER and Fluoxetine in people with Major Depressive Disorder, run by Allergan at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Children's Depression Rating Scale- Revised (CDRS-R) (time frame: Baseline (Week 0) to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03569475, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.