Major Depressive DisorderPhase 2NCT01254305

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder

A Phase 2 study testing Levomilnacipran ER and Paroxetine, Sertraline, Citalopram or Fluoxetine. in people with Major Depressive Disorder, run by Forest Laboratories at 20 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Levomilnacipran ER and Paroxetine, Sertraline, Citalopram or Fluoxetine.
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 262 participants
Where: 20 sitesUnited States
Study dates: Apr 2011to Jul 2012
Phase: Phase 2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women, 18-65 years old
Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder
The patient's current depressive episode must be at least 4 weeks in duration

Who cannot join

Women who are pregnant, women who will be breastfeeding during the study, and women of child-bearing potential who are not practicing a reliable method of birth control
Patients with a history of meeting DSM-IV-TR criteria for:
any manic or hypomanic episode;
schizophrenia or any other psychotic disorder;
obsessive-compulsive disorder.
Patients who are considered a suicide risk

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Forest Investigative Site 009
Atlanta, Georgia, 30308
Forest Investigative Site 010
Birmingham, Alabama, 35216
Forest Investigative Site 022
Boston, Massachusetts, 02135
Forest Investigative Site 015
Cedarhurst, New York, 11516
Forest Investigative Site 001
Cerritos, California, 90703
Forest Investigative Site 003
Cincinnati, Ohio, 45227
Forest Investigative Site 008
Dallas, Texas, 75235
Forest Investigative Site 013
Dayton, Ohio, 45417
Forest Investigative Site 014
Fort Myers, Florida, 33912
Forest Investigative Site 006
Jacksonville, Florida, 32216
Forest Investigative Site 016
Joliet, Illinois, 60435
Forest Investigative Site 020
Lincoln, Rhode Island, 02865
Forest Investigative Site 002
Little Rock, Arkansas, 72223
Forest Investigative Site 018
Memphis, Tennessee, 38119
Forest Investigative Site 007
Middleton, Wisconsin, 53562
Forest Investigative Site 004
New Orleans, Louisiana, 70122
Forest Investigative Site 017
Orange City, Florida, 32763
Forest Investigative Site 005
Orlando, Florida, 32806
Forest Investigative Site 012
Tampa, Florida, 33613
Forest Investigative Site 011
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder

The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).

Conditions: Major Depressive Disorder
Being tested: Levomilnacipran ER, Paroxetine, Sertraline, Citalopram or Fluoxetine., Placebo
Keywords: Depression, Fatigue, Major Depressive Disorder
Medical subject headings: Depressive Disorder, Major, Depression, Fatigue

What participants receive

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

Levomilnacipran ERDrug
Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks
Paroxetine, Sertraline, Citalopram or Fluoxetine.Drug
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks
PlaceboDrug
Matching placebo capsules, oral administration, once daily dosing

Study groups in NCT01254305
Study group	Role	What they receive
1	Experimental	40 -120 mg/day Levomilnacipran ER capsules, oral administration Receives: Drug: Levomilnacipran ER
2	Active comparator	Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing Receives: Drug: Paroxetine, Sertraline, Citalopram or Fluoxetine.
3	Placebo comparator	Matching placebo capsules, oral administration Receives: Drug: Placebo

What is being measured

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

Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score
The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued
Measured: From Baseline to Week 8
Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score
The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.
Measured: From Baseline to Week 8

Secondary outcomes (1)

Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward
The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems-with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent).
Measured: From Baseline to Week 8

Timeline

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

Apr 2011Jul 2012

First posted6 Dec 2010 (estimated)
Study startApr 2011
Primary completionJul 2012
Study completionJul 2012

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 262 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01254305
Sponsor's protocol ID: LVM-MD-06
Status last verified: Aug 2014
First submitted: 3 Dec 2010
Last updated: 6 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01254305
Acronym / sponsor ID: LVM-MD-06
Conditions: Major Depressive Disorder
Keywords: Depression, Fatigue, Major Depressive Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 262 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 6 Dec 2010 (estimated)
Results: Posted 6 Aug 2014

Clinical summary

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

The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).

Study design

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

Arm	Type	Receives
1	Experimental	Drug: Levomilnacipran ER40 -120 mg/day Levomilnacipran ER capsules, oral administration
2	Active comparator	Drug: Paroxetine, Sertraline, Citalopram or Fluoxetine.Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing
3	Placebo comparator	Drug: PlaceboMatching placebo capsules, oral administration

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Men and women, 18-65 years old
Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder
The patient's current depressive episode must be at least 4 weeks in duration

Key exclusion criteria (6 listed)

Women who are pregnant, women who will be breastfeeding during the study, and women of child-bearing potential who are not practicing a reliable method of birth control
Patients with a history of meeting DSM-IV-TR criteria for:
Patients who are considered a suicide risk

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 ERDrug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks	Drug	1
Paroxetine, Sertraline, Citalopram or Fluoxetine.Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks	Drug	2
PlaceboMatching placebo capsules, oral administration, once daily dosing	Drug	3

Primary outcome

Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score
Time frame: From Baseline to Week 8
The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued
Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score
Time frame: From Baseline to Week 8
The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.

1 secondary outcome

Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward
Time frame: From Baseline to Week 8

Results and safety

Results posted to the registry on 6 Aug 2014, 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	93	71
Levomilnacipran ER	90	72
SSRI	79	62

Primary outcome: Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score

Time frame: From Baseline to Week 8. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 88	Levomilnacipran ER n = 85	SSRI n = 75
Value	-1.5 (1.3)	-1.8 (1.4)	-1.9 (1.4)

Population analysed: The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population. The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score.

Primary outcome: Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score

Time frame: From Baseline to Week 8. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 88	Levomilnacipran ER n = 85	SSRI n = 75
Value	-1.4 (1.5)	-1.7 (1.5)	-1.7 (1.5)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 89 (0%)	39 of 89 (43.8%)	Not reported
Levomilnacipran ER	1 of 85 (1.2%)	41 of 85 (48.2%)	Not reported
SSRI	0 of 77 (0%)	37 of 77 (48.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Carl Gommoll, MS study director

Forest Laboratories

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Levomilnacipran ER and Paroxetine, Sertraline, Citalopram or Fluoxetine. in people with Major Depressive Disorder, run by Forest Laboratories at 20 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 3 inclusion and 6 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 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Aug 2014). 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 in Clinical Global Impression of Severity (CGI-S) for Fatigue Score (time frame: From Baseline to Week 8). The study lists 2 primary outcomes in all. 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 NCT01254305.

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 6 Aug 2014.