Exploration of the Potential Mechanisms of n-3 Fatty Acids Supplementation in Depression and Cognitive Function in Patients With Late-life Depression

NCT05972798 | Completed

• 1 other identifier: 201701653B0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Depression in the elderly causes considerable distress, disability, and loss of life. The accelerating aging boom is accentuating the importance of addressing late life depression (LLD). Extensive efforts in searching for effective and safety treatment yielded unsatisfactory results. Among the multiple agents in LLD treatment, long-chain polyunsaturated omega-3 fatty acids (omega-3 PUFA) stands out as an interesting compound as it addressed two main features in LLD, depressive mood and cognitive function. However, how it affects the brain remains unknown. Therefore, in an on-going double-blind randomized placebo-controlled study using 48 weeks omega-3 PUFA supplement in LLD treatment, we plan to perform two MRI scans (pre-treatment and post-treatment), in an effort to understand the unique neurobiology of omega-3 PUFA in the treatment of LLD. Along the trial, neuropsychological function and associated inflammatory markers were also collected.

Conditions

Late Life Depression

Keywords

elderly depression; long-chain polyunsaturated omega-3 fatty acids; cognitive function

Outcome Measures

Primary Outcomes (3)

• Loneliness UCLA

  the severity of loneliness (the score range from 20-80,the lower score means worse)

  Change from Baseline at 52 weeks

• Ham D-17

  the insight(the score range from 0-2,the higher score means worse)

  Change from Baseline at 52 weeks

• Geriatric Depression Geriatric Depression Scale-15

  the insight(the score range from 0-1,the higher score means worse)

  Change from Baseline at 52 weeks

Secondary Outcomes (10)

• Pittsburgh Sleep Quality Index (PSQI)

  Change from Baseline at 52 weeks

• Hamilton Rating Scale for Anxiety (HAM-A)

  Change from Baseline at 52 weeks

• Verbal Learning & Memory

  Change from Baseline at 52 weeks

• structural and functional connectivity

  Change from Baseline at 52 weeks

• Mini-Mental State Examination (MMSE)

  Change from Baseline at 52 weeks

Study Arms (2)

Omega-3 fatty acids

EXPERIMENTAL

1. Age \> 60 years. 2. Previous major depressive disorder (MDD), single or recurrent. 3. Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10

Other: Omega-3 fatty acids

Soybean oil

PLACEBO COMPARATOR

1. Age \> 60 years. 2. Previous major depressive disorder (MDD), single or recurrent. 3. Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10

Other: Soybean oil

Interventions

Omega-3 fatty acids OTHER

2.2 g/d omega-3 PUFAs (1.2g EPA and 1g DHA per day) in patients with LLD

Omega-3 fatty acids

Soybean oil OTHER

Soybean oil in patients with LLD

Soybean oil

Eligibility Criteria

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

You may qualify if:

• Age \> 60 years.
• Previous major depressive disorder (MDD), single or recurrent.
• Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10

You may not qualify if:

• Inability to provide informed consent.
• Depressive symptoms severe enough (i.e., HAMD-17 \>= 10) at the baseline.
• Dementia, as defined by MMSE \< 24 and clinical evidence of dementia.
• Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
• Abuse of or dependence on alcohol or other substances within the past 3 months, and confirmed by study physician interview.
• High risk for suicide (e.g., active SI and/or current/recent intent or plan) AND unable to be managed safely in the clinical trial (e.g., unwilling to be hospitalized). Urgent psychiatric referral will be made in these cases.
• Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
• Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management. This will be determined based on information from the patient's personal physician and study physician's clinical judgment.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Che-min Lin

Keelung, Taiwan

Location

MeSH Terms

Interventions

Fatty Acids, Omega-3; Soybean Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: September 25, 2018
• Primary Completion: September 25, 2018
• Study Completion: December 25, 2020
• Last Updated: August 2, 2023

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)