Trial of Levomilnacipran in Geriatric Depression

NCT02466958 | Completed Phase 4 Results DMC

• 1 other identifier: IIT-USA-000620
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

depressed; older adults; antidepressants; depression; MDD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks

Secondary Outcomes (2)

• Clinical Global Impression Scale (CGI) Scores

  Week 12 reported

• Geriatric Depression (GDS) Scores

  Baseline and 12 weeks

Study Arms (2)

levomilnacipran (FETZIMA)

ACTIVE COMPARATOR

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.

Drug: levomilnacipran

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

levomilnacipran DRUG

antidepressant

Also known as: FETZIMA

levomilnacipran (FETZIMA)

Placebo DRUG

an inactive drug

Also known as: inactive substance

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute - Neuropsychiatric Institute (NPI)

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• 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.

  PMID: 31332902 RESULT

• 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.

  PMID: 33757609 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Consciousness Disorders; Depression

Interventions

Levomilnacipran

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Milnacipran; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Helen Lavretsky, MD
• Organization: UCLA

HLavretsky@mednet.ucla.edu

310-794-4619

Study Officials

• Helen Lavretsky, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2016
• Primary Completion: December 9, 2018
• Study Completion: December 9, 2018
• Last Updated: August 14, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)