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Trial of Levomilnacipran in Geriatric Depression (LMIL)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
levomilnacipran
Placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depressed, older adults, antidepressants, depression, MDD

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 60 years of age or older
  • The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual and Mental Disorders, 5th edition (DSM-V) criteria
  • A 24-item Hamilton Rating Scale for Depression (HAMD) score of 16 or higher at baseline
  • Mini-Mental State Exam (MMSE) score > 24.

Exclusion Criteria:

Subjects will be excluded if they had 1) any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or 2) recent unstable medical or neurological disorders; 3) any disabilities preventing participation in the study or in the MRI; 4) diagnosis of dementia; 5) acute suicidality; 6) subjects with known allergic reactions to milnacipran, uncontrolled narrow angle glaucoma, seizures, poorly-controlled hypertension or ischemic changes on ECG, serotonin syndrome, or the recently used monoamine oxidase inhibitors (MAOIs) within last 4 weeks; 7) ineligible for MRI (e.g., metal in the body or claustrophobia)

Sites / Locations

  • UCLA Semel Institute - Neuropsychiatric Institute (NPI)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

levomilnacipran (FETZIMA)

Placebo

Arm Description

All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.

All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS) Scores 24
This measure includes 24 items. Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range [0-74], higher scores representing more severe difficulties.

Secondary Outcome Measures

Clinical Global Impression Scale (CGI) Scores
7-Point Likert Scale [1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse].
Geriatric Depression (GDS) Scores
The GDS has a total of 30 items with response options [Yes/No]. Total score range is [0-30]. Higher scores represent more severe difficulties.

Full Information

First Posted
May 29, 2015
Last Updated
August 2, 2019
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02466958
Brief Title
Trial of Levomilnacipran in Geriatric Depression
Acronym
LMIL
Official Title
Double-blind Placebo-controlled Trial of Levomilnacipran in Geriatric Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 9, 2018 (Actual)
Study Completion Date
December 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine the effects of levomilnacipran (FETZIMA) compared to placebo for the treatment of depression in older adults.
Detailed Description
A 12-week pilot double-blind comparison of levomilnacipran (FETZIMA) to placebo for the treatment of geriatric depression. The investigators are interested in assessing the efficacy of levomilnacipran (LMIL) to placebo (PBO), and exploring the effects of antidepressant response on brain connectivity and neuroplasticity. This pilot study is designed to determine any differences in the efficacy, safety and tolerability of levomilnacipran compared to placebo, and to perform dose finding (20-120 mg per day) in 40 older depressed adults. The investigators anticipate that the LMIL will be superior to PBO in improving levels of depressive symptoms and rates of remission, as well as improving cognition, apathy, and quality of life. This proposal expands the investigator's focus on the biomarkers of neuroplasticity that have been used in several prior studies and demonstrated responsivity to antidepressant treatment. The purpose is to examine this directly in 40 older adults with major depression. This proposed trial will also serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and the dose-finding in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depressed, older adults, antidepressants, depression, MDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
levomilnacipran (FETZIMA)
Arm Type
Active Comparator
Arm Description
All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.
Intervention Type
Drug
Intervention Name(s)
levomilnacipran
Other Intervention Name(s)
FETZIMA
Intervention Description
antidepressant
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
inactive substance
Intervention Description
an inactive drug
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS) Scores 24
Description
This measure includes 24 items. Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range [0-74], higher scores representing more severe difficulties.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression Scale (CGI) Scores
Description
7-Point Likert Scale [1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse].
Time Frame
Week 12 reported
Title
Geriatric Depression (GDS) Scores
Description
The GDS has a total of 30 items with response options [Yes/No]. Total score range is [0-30]. Higher scores represent more severe difficulties.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 years of age or older The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual and Mental Disorders, 5th edition (DSM-V) criteria A 24-item Hamilton Rating Scale for Depression (HAMD) score of 16 or higher at baseline Mini-Mental State Exam (MMSE) score > 24. Exclusion Criteria: Subjects will be excluded if they had 1) any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or 2) recent unstable medical or neurological disorders; 3) any disabilities preventing participation in the study or in the MRI; 4) diagnosis of dementia; 5) acute suicidality; 6) subjects with known allergic reactions to milnacipran, uncontrolled narrow angle glaucoma, seizures, poorly-controlled hypertension or ischemic changes on ECG, serotonin syndrome, or the recently used monoamine oxidase inhibitors (MAOIs) within last 4 weeks; 7) ineligible for MRI (e.g., metal in the body or claustrophobia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Lavretsky, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Semel Institute - Neuropsychiatric Institute (NPI)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31332902
Citation
Krause-Sorio B, Kilpatrick L, Siddarth P, Ercoli L, Laird KT, Aguilar-Faustino Y, Milillo MM, Narr KL, Lavretsky H. Cortical thickness increases with levomilnacipran treatment in a pilot randomised double-blind placebo-controlled trial in late-life depression. Psychogeriatrics. 2020 Mar;20(2):140-148. doi: 10.1111/psyg.12475. Epub 2019 Jul 22.
Results Reference
result
PubMed Identifier
33757609
Citation
Lee SM, Dong TS, Krause-Sorio B, Siddarth P, Milillo MM, Lagishetty V, Datta T, Aguilar-Faustino Y, Jacobs JP, Lavretsky H. The intestinal microbiota as a predictor for antidepressant treatment outcome in geriatric depression: a prospective pilot study. Int Psychogeriatr. 2022 Jan;34(1):33-45. doi: 10.1017/S1041610221000120. Epub 2021 Mar 24.
Results Reference
derived

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Trial of Levomilnacipran in Geriatric Depression

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