A Phase 3 interventional study of Levomilnacipran ER and Placebo in Depression and Major Depressive Disorder, sponsored by Forest Laboratories. Completed at 35 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Forest Laboratories (part of AbbVie) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).
Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 734 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Forest Laboratories is the lead sponsor of 168 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
First submitted before Forest Laboratories became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with a history of meeting criteria for:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.
Drug: Levomilnacipran ER
Matching placebo capsules, oral administration, once daily dosing.
Drug: Placebo
Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
Matching placebo to be given orally, in capsule form, once daily.
Time to Relapse (Days)
Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4
Time frame: 24 Weeks
Patient were recruited over a 10-month period from March of 2010 to January of 2011 at 36 studies sites, 30 in the United States and 6 in Canada.
| Milestone | Placebo | Levomilnacipran ER |
|---|---|---|
| Started | 0 | 734 |
| Completed | 0 | 494 |
| Not completed | 0 | 240 |
| Withdrew: Adverse event | 0 | 80 |
| Withdrew: Lack of efficacy | 0 | 26 |
| Withdrew: Protocol violation | 0 | 39 |
| Withdrew: Withdrawal by subject | 0 | 53 |
| Withdrew: Lost to follow-up | 0 | 42 |
| Milestone | Placebo | Levomilnacipran ER |
|---|---|---|
| Started | 113 | 235 |
| Completed | 92 | 177 |
| Not completed | 21 | 58 |
| Withdrew: Adverse event | 3 | 8 |
| Withdrew: Protocol violation | 2 | 7 |
| Withdrew: Withdrawal by subject | 11 | 24 |
| Withdrew: Lost to follow-up | 5 | 17 |
| Withdrew: Other reasons | 0 | 2 |
| Milestone | Placebo | Levomilnacipran ER |
|---|---|---|
| Started | 112 | 230 |
| Completed | 92 | 174 |
| Not completed | 20 | 56 |
| Withdrew: Adverse event | 3 | 8 |
| Withdrew: Protocol violation | 2 | 7 |
| Withdrew: Withdrawal by subject | 11 | 22 |
| Withdrew: Lost to follow-up | 4 | 17 |
| Withdrew: Positive serum pregnancy test result | 0 | 2 |
Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4
| Days | Placebo | Levomilnacipran ER |
|---|---|---|
| Time to Relapse (Days) | NA ± NA | NA ± NA |
Collected over Adverse event data was collection over a 20-month period from March 2010 to November 2011 at 36 study sites in the U.S and Canada.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Label Levomilnacipran ER | 0/734 (0%) | 7/734 (1%) | 448/734 (61%) |
| Placebo - Double Blind Treatment | 0/112 (0%) | 4/112 (3.6%) | 31/112 (27.7%) |
| Levomilnacipran ER - Double Blind Treatment | 0/233 (0%) | 2/233 (0.9%) | 68/233 (29.2%) |
| Event | Open Label Levomilnacipran ER | Placebo - Double Blind Treatment | Levomilnacipran ER - Double Blind Treatment |
|---|---|---|---|
| Blood pressure increasedInvestigations | 0/734 | 1/112 | 0/233 |
| CellulitisInfections and infestations | 0/734 | 1/112 | 0/233 |
| Deep vein thrombosisVascular disorders | 0/734 | 1/112 | 0/233 |
| Drug hypersensitivityImmune system disorders | 0/734 | 1/112 | 0/233 |
| PneumoniaInfections and infestations | 0/734 | 1/112 | 0/233 |
| Intestinal ischaemiaGastrointestinal disorders | 0/734 | 0/112 | 1/233 |
| Non-cardiac chest painGeneral disorders | 0/734 | 0/112 | 1/233 |
| Ankle fractureInjury, poisoning and procedural complications | 1/734 | 0/112 | 0/233 |
| Blood creatine phosphokinase MB increasedInvestigations | 1/734 | 0/112 | 0/233 |
| Chest painGeneral disorders | 1/734 | 0/112 | 0/233 |
| Event | Open Label Levomilnacipran ER | Placebo - Double Blind Treatment | Levomilnacipran ER - Double Blind Treatment |
|---|---|---|---|
| NauseaGastrointestinal disorders | 160/734 | 5/112 | 13/233 |
| HeadacheNervous system disorders | 141/734 | 11/112 | 31/233 |
| ConstipationGastrointestinal disorders | 82/734 | 5/112 | 2/233 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 80/734 | 1/112 | 4/233 |
| DizzinessNervous system disorders | 78/734 | 5/112 | 4/233 |
| Dry mouthGastrointestinal disorders | 78/734 | 1/112 | 3/233 |
| Upper respiratory tract infectionInfections and infestations | 51/734 | 10/112 | 17/233 |
| Erectile dysfunctionReproductive system and breast disorders | 27/309 | 1/51 | 1/94 |
| NasopharyngitisInfections and infestations | 25/734 | 9/112 | 20/233 |
| InsomniaPsychiatric disorders | 63/734 | 5/112 | 5/233 |
The Baseline Participant population is based on the 734 enrolled patients who received at least one dose of open-label treatment.
| Age, Continuous(years) | Open Label Levomilnacipran ER |
|---|---|
| Mean | 42.2 ± 12.3 |
| Age, Customized(Participants) | Open Label Levomilnacipran ER |
|---|---|
| 18 years to 19 years | 8 |
| 20 years to 29 years | 151 |
| 30 years to 39 years | 127 |
| 40 years to 49 years | 208 |
| 50 years to 59 years | 186 |
| 60 years to 65 years | 54 |
| Sex: Female, Male(Participants) | Open Label Levomilnacipran ER |
|---|---|
| Female | 425 |
| Male | 309 |
| Region of Enrollment(Participants) | Open Label Levomilnacipran ER |
|---|---|
| United States | 683 |
| Canada | 51 |
| Weight(kg) | Open Label Levomilnacipran ER |
|---|---|
| Mean | 83.41 ± 18.43 |
| Body Mass Index (BMI)(Kilograms Per Meter Squared) | Open Label Levomilnacipran ER |
|---|---|
| Mean | 28.88 ± 5.42 |
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Levomilnacipran