The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)in Tokyo: Open Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-09

Study Completion Date

2017-11-11

Brief Summary

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The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.

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Detailed Description

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Conditions

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Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Omega-3 polyunsaturated fatty acids

1200mg EPA and 600mg DHA daily

Group Type EXPERIMENTAL

Omega-3 polyunsaturated fatty acids

Intervention Type DIETARY_SUPPLEMENT

Placebo Comparator

320 mg olive oil and 9.9 mg omega-3 PUFAs

Group Type PLACEBO_COMPARATOR

Omega-3 polyunsaturated fatty acids

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Omega-3 polyunsaturated fatty acids

Intervention Type DIETARY_SUPPLEMENT

Omega-3 polyunsaturated fatty acids

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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1200mg EPA and 600mg DHA daily 320 mg olive oil and 9.9 mg omega-3 PUFAs

Eligibility Criteria

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Inclusion Criteria

1. pregnant women aged 20 years or older.
2. between 12-24 weeks gestation.
3. a Japanese conversational ability to understand the scope of the present trial.
4. planned to return to the hospital for checkup at 4-6 weeks after childbirth.
5. an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more.
6. to have good physical health judged by obstetricians.

Exclusion Criteria

1. history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder.
2. the item of EPDS concerning suicide ideation is 2 or more.
3. other serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment.
4. difficult to expect a normal birth (ex: fetal malformation etc.).
5. having a history of bleeding disorder such as von Willebrand's Disease.
6. regular treatment with aspirin or warfarin within the last 3 months.
7. a smoking habit of ≥40 cigarettes per day.
8. regular treatment with ethyl icosapentate or regular consumption of omega- 3 PUFA supplements within the last 3 months.
9. a habit of eating fish ≥4 times per week.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No