DepressionPhase 2NCT00402389
Use of Omega-3 Fatty Acids for Perinatal Depression
A Phase 2 study testing Omega-3 Fatty Acids (EPA plus DHA) and Supportive psychotherapy in people with Depression and Depression, Postpartum, run by University of Arizona at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depression, Depression, Postpartum
- What is being tested?
- Omega-3 Fatty Acids (EPA plus DHA) and Supportive psychotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who are pregnant (12 to 32 weeks gestation) or postpartum
- Meets criteria for a major depressive episode
- Scores a minimum of 9 on the Edinburgh Postnatal Depression scale
- Must be able to be treated on an outpatient basis
Who cannot join
- Known intolerance or allergy to omega-3 fatty acid or fish oil
- Presently taking antidepressant medication
- Currently using heparin or warfarin (compounds used to prevent blood from clotting)
- Presence of psychotic symptoms
- History of mania (abnormally elevated mood state) or hypomania (same as mania but occurs at a much lesser degree)
- Active suicidal ideation (desire to commit suicide)
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Mental Health Program; University of Arizona; Department of Psychiatry
Tucson, Arizona, 85724
About this study
Official title: Randomized Controlled Trial of Omega-3 Fatty Acids for Perinatal Depression
This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal depression.
Read the detailed description
Depression is the chief cause of disease-associated disability in women. Because of the highs and lows during pregnancy through the first year of motherhood, expectant and new mothers are particularly prone to depression. Approximately 10% to 15% of women experience perinatal depression, which includes depression during pregnancy and/or postpartum depression. Signs of perinatal depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in the infant or family activities; excessive irritability and restlessness; thoughts of hurting self or infant; inability to concentrate; and lack of enjoyment in previously enjoyed activities. Depression occurring during pregnancy and postpartum can have a negative impact on the development and health of the baby. Additionally, maternal stress in humans is associated with lower birth weights and lower gestational ages at birth. Currently, there is a lack of knowledge on the use of antidepressants during pregnancy and postpartum, making this a significant health issue. Earlier studies have suggested that a depletion of omega-3 fatty acids during pregnancy might be the cause of depression and mood disorders in pregnant women. This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal depression.
Participation in this double-blind study will last about 9 weeks. All participants will attend an initial screening visit and subsequent study visits, which will occur bi-weekly throughout the treatment phase. During these visits, participants will be asked questions about their medical and substance use history, demographic information, and eating behaviors. Participants will also complete questionnaires and interviews that will be used to assess their mental status, depression levels, marital/partner satisfaction levels, social/functional abilities, and overall mood levels. After the initial screening visit, eligible participants will be randomly assigned to receive either omega-3 fatty acids or placebo capsules. Participants in each group will be required to take four capsules on a daily basis for 8 weeks. During this treatment phase, all participants will also attend six weekly 30-minute supportive psychotherapy sessions. Blood samples for omega-3 fatty acid analysis will be taken on the first and last visits.
- Conditions
- Depression, Depression, Postpartum
- Being tested
- Omega-3 Fatty Acids (EPA plus DHA), Supportive psychotherapy, Placebo
- Keywords
- Perinatal Depression, Postpartum Depression, Omega-3 Fatty Acids, Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA), Pregnancy, Psychotherapy
- Medical subject headings
- Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty Acids (EPA plus DHA)Drug
Four capsules will be taken daily for 8 weeks.
Supportive psychotherapyBehavioural
Supportive psychotherapy will provide education to increase understanding of the condition, guidance on how to cope with depression, and methods on how to improve self-esteem.
PlaceboDrug
Four capsules will be taken daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants assigned to take omega-3 fatty acids Receives: Drug: Omega-3 Fatty Acids (EPA plus DHA); Behavioral: Supportive psychotherapy |
| 2 | Placebo comparator | Participants assigned to take placebo Receives: Behavioral: Supportive psychotherapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more
Measured: Measured at Week 8
Reduction of EPDS score to less than or equal to 9
Measured: Measured at Week 8
CGI change score achievement of "very much improved" or "much improved"
Measured: Measured at Week 8
Secondary outcomes (2)
Significant reductions in outcome measures of functional status and reduction of SIGH-ADS score of 50%
Measured: Measured at Week 8
Changes in the level of omega-3 fatty acid composition of red blood cell membranes
Measured: Measured at Weeks 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startJun 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Marlene P. Freeman, MD, Principal investigator, University of Arizona; Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402389
- Sponsor's protocol ID
- K23MH066265
- Other IDs
- K23MH066265, DATR AK-TNAI2
- Status last verified
- Mar 2013
- First submitted
- 20 Nov 2006
- Last updated
- 29 Mar 2013
- Results posted
- No
Publications
Freeman MP, Hibbeln JR, Wisner KL, Brumbach BH, Watchman M, Gelenberg AJ. Randomized dose-ranging pilot trial of omega-3 fatty acids for postpartum depression. Acta Psychiatr Scand. 2006 Jan;113(1):31-5. doi: 10.1111/j.1600-0447.2005.00660.x.
PubMed 16390366
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Omega-3 Fatty Acids for Perinatal Depression
- ClinicalTrials.gov ID
- NCT00402389
- Acronym / sponsor ID
- K23MH066265
- Conditions
- Depression, Depression, Postpartum
- Keywords
- Perinatal Depression, Postpartum Depression, Omega-3 Fatty Acids, Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA), Pregnancy, Psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal depression.
Detailed description
Depression is the chief cause of disease-associated disability in women. Because of the highs and lows during pregnancy through the first year of motherhood, expectant and new mothers are particularly prone to depression. Approximately 10% to 15% of women experience perinatal depression, which includes depression during pregnancy and/or postpartum depression. Signs of perinatal depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in the infant or family activities; excessive irritability and restlessness; thoughts of hurting self or infant; inability to concentrate; and lack of enjoyment in previously enjoyed activities. Depression occurring during pregnancy and postpartum can have a negative impact on the development and health of the baby. Additionally, maternal stress in humans is associated with lower birth weights and lower gestational ages at birth. Currently, there is a lack of knowledge on the use of antidepressants during pregnancy and postpartum, making this a significant health issue. Earlier studies have suggested that a depletion of omega-3 fatty acids during pregnancy might be the cause of depression and mood disorders in pregnant women. This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal depression.
Participation in this double-blind study will last about 9 weeks. All participants will attend an initial screening visit and subsequent study visits, which will occur bi-weekly throughout the treatment phase. During these visits, participants will be asked questions about their medical and substance use history, demographic information, and eating behaviors. Participants will also complete questionnaires and interviews that will be used to assess their mental status, depression levels, marital/partner satisfaction levels, social/functional abilities, and overall mood levels. After the initial screening visit, eligible participants will be randomly assigned to receive either omega-3 fatty acids or placebo capsules. Participants in each group will be required to take four capsules on a daily basis for 8 weeks. During this treatment phase, all participants will also attend six weekly 30-minute supportive psychotherapy sessions. Blood samples for omega-3 fatty acid analysis will be taken on the first and last visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Omega-3 Fatty Acids (EPA plus DHA), Behavioral: Supportive psychotherapyParticipants assigned to take omega-3 fatty acids |
| 2 | Placebo comparator | Behavioral: Supportive psychotherapy, Drug: PlaceboParticipants assigned to take placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women who are pregnant (12 to 32 weeks gestation) or postpartum
- Meets criteria for a major depressive episode
- Scores a minimum of 9 on the Edinburgh Postnatal Depression scale
- Must be able to be treated on an outpatient basis
Key exclusion criteria (6 listed)
- Known intolerance or allergy to omega-3 fatty acid or fish oil
- Presently taking antidepressant medication
- Currently using heparin or warfarin (compounds used to prevent blood from clotting)
- Presence of psychotic symptoms
- History of mania (abnormally elevated mood state) or hypomania (same as mania but occurs at a much lesser degree)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty Acids (EPA plus DHA)Four capsules will be taken daily for 8 weeks. | Drug | 1 |
| Supportive psychotherapySupportive psychotherapy will provide education to increase understanding of the condition, guidance on how to cope with depression, and methods on how to improve self-esteem. | Behavioural | 1, 2 |
| PlaceboFour capsules will be taken daily for 8 weeks. | Drug | 2 |
Primary outcome
Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more
Time frame: Measured at Week 8
Reduction of EPDS score to less than or equal to 9
Time frame: Measured at Week 8
CGI change score achievement of "very much improved" or "much improved"
Time frame: Measured at Week 8
2 secondary outcomes
Significant reductions in outcome measures of functional status and reduction of SIGH-ADS score of 50%
Time frame: Measured at Week 8
Changes in the level of omega-3 fatty acid composition of red blood cell membranes
Time frame: Measured at Weeks 1 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Results publication: PubMed 16390366Freeman MP, Hibbeln JR, Wisner KL, Brumbach BH, Watchman M, Gelenberg AJ. Randomized dose-ranging pilot trial of omega-3 fatty acids for postpartum depression. Acta Psychiatr Scand. 2006 Jan;113(1):31-5. doi: 10.1111/j.1600-0447.2005.00660.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene P. Freeman, MD principal investigator
University of Arizona; Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 Fatty Acids (EPA plus DHA) and Supportive psychotherapy in people with Depression and Depression, Postpartum, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more (time frame: Measured at Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.