Major Depressive DisorderSADFATNCT00963196
Study of Supplementation of Antidepressants With Fish Oil to Improve Time to Clinical Response
A study testing Omega-3 fatty acid and Bovine gelatin capsules in people with Major Depressive Disorder, run by University of Virginia at 1 site in United States.
Trial summary
This study will be a randomized controlled trial set in an outpatient clinic, involving patients with major depressive disorder, who will be treated with antidepressant therapy, which will be individually agreed upon by the subject and his or her physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Omega-3 fatty acid and Bovine gelatin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major Depressive Disorder.
- Allowed comorbidities: Dysthymia, Anxiety Disorders.
- 18 years old or older.
- Males + Females.
- English-speaking.
- Women of reproductive age must be on adequate birth control, either oral contraceptives or using condoms or other barrier methods with spermicidal agents.
- Subjects may be undergoing psychotherapy, but must maintain current psychotherapy status. Must not start therapy if not already in therapy. If in therapy, must have received at least 6 sessions prior to entering the study.
- Subjects may continue taking herbals or supplements during the study, but they may not start any new herbals or supplements during the study.
Who cannot join
- 2 or more failed trials of antidepressants (adequate dose and duration, and documented).
- Substance dependence in the past 6 months.
- Current substance use or abuse (MJ, benzodiazepines, narcotics). If BZD use, patient must be tapered off and wait 1 month before being included in the trial.
- Psychosis.
- Bipolar Affective Disorder Type I, II or NOS.
- Pregnancy (current or planned).
Show all 15Show fewer
- Unstable medical illness (pt has to be stable for at least 3 months, and may be excluded per investigator discretion).
- Dementia.
- Mental retardation.
- Traumatic Brain Injury.
- History of Stroke.
- History of seizure disorder.
- Electroconvulsive therapy within past 6 months.
- If, at the investigator's discretion, it is suspected that the subject will likely not comply with the study protocol.
- Imminent risk for suicide.
Trial locations and contacts
1 site in 1 country.
United States1 site
UVA Psychiatry Outpatient Clinic
Charlottesville, Virginia, 22908
About this study
Official title: Supplementation of Antidepressants With Fatty Acid Therapy
This study will be a randomized controlled trial set in an outpatient clinic, involving patients with major depressive disorder, who will be treated with antidepressant therapy, which will be individually agreed upon by the subject and his or her physician. Patients will be randomized to receive either placebo or fish oil capsules containing eicosapentaenoic acid (EHA) and docosahexaenoic acid (DHA) in addition to their antidepressant medication. Subjects will complete a brief dietary and exercise habits survey at the beginning of the trial to take into account lifestyle factors that may be significant in symptom resolution. Their progress will be monitored over a period of twelve weeks, with standardized rating scales completed by subjects and treating physicians. At the end of the study, scores will be compared between groups to look for differences in timing and degree of symptom improvement to analyze whether improvement occurred faster in the group receiving essential fatty acids (EFAs) than in the one receiving placebo. The primary hypothesis is that supplementation of antidepressant therapy with omega-3 fatty acids will decrease the lag period between the start of therapy and the time of clinically significant symptom improvement. A secondary hypothesis is that the results of this study will be consistent with numerous previous studies showing improvement in symptom control in major depressive disorder when antidepressants are supplemented with omega-3 fatty acids.
- Conditions
- Major Depressive Disorder
- Being tested
- Omega-3 fatty acid, Bovine gelatin capsules
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidDietary supplement
2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks
Bovine gelatin capsulesDrug
Bovine gelatin capsules that appear similar to active drug acting as placebo.
| Study group | Role | What they receive |
|---|---|---|
| One unsuccessful trial | Active comparator | Patients with one unsuccessful previous antidepressant trial Receives: Dietary Supplement: Omega-3 fatty acid; Drug: Bovine gelatin capsules |
| One successful trial | Active comparator | Patients with one previous successful antidepressant trial Receives: Dietary Supplement: Omega-3 fatty acid; Drug: Bovine gelatin capsules |
| No previous trial | Active comparator | Patients with no prior antidepressant therapy Receives: Dietary Supplement: Omega-3 fatty acid; Drug: Bovine gelatin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in MADRS and PHQ-9 scores occurs in a shorter period of time in the intervention group versus the placebo group.
Measured: 12 weeks
Secondary outcomes (1)
Subjects in the intervention group experience greater reduction of scores in MADRS and PHQ-9 than the placebo group.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Why it stopped: End of allotted time for subject recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Anita H Clayton, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963196
- Sponsor's protocol ID
- 14503
- Acronym
- SADFAT
- Status last verified
- Jun 2010
- First submitted
- 20 Aug 2009
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hallahan B, Garland MR. Essential fatty acids and mental health. Br J Psychiatry. 2005 Apr;186:275-7. doi: 10.1192/bjp.186.4.275. No abstract available.
PubMed 15802681Hallahan B, Garland MR. Essential fatty acids and their role in the treatment of impulsivity disorders. Prostaglandins Leukot Essent Fatty Acids. 2004 Oct;71(4):211-6. doi: 10.1016/j.plefa.2004.03.006.
PubMed 15301790Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213. doi: 10.1016/S0140-6736(05)79168-6. No abstract available.
PubMed 9643729Gesch CB, Hammond SM, Hampson SE, Eves A, Crowder MJ. Influence of supplementary vitamins, minerals and essential fatty acids on the antisocial behaviour of young adult prisoners. Randomised, placebo-controlled trial. Br J Psychiatry. 2002 Jul;181:22-8. doi: 10.1192/bjp.181.1.22.
PubMed 12091259Pischon T, Hankinson SE, Hotamisligil GS, Rifai N, Willett WC, Rimm EB. Habitual dietary intake of n-3 and n-6 fatty acids in relation to inflammatory markers among US men and women. Circulation. 2003 Jul 15;108(2):155-60. doi: 10.1161/01.CIR.0000079224.46084.C2. Epub 2003 Jun 23.
PubMed 12821543Stoll AL, Severus WE, Freeman MP, Rueter S, Zboyan HA, Diamond E, Cress KK, Marangell LB. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1999 May;56(5):407-12. doi: 10.1001/archpsyc.56.5.407.
PubMed 10232294Tanskanen A, Hibbeln JR, Hintikka J, Haatainen K, Honkalampi K, Viinamaki H. Fish consumption, depression, and suicidality in a general population. Arch Gen Psychiatry. 2001 May;58(5):512-3. doi: 10.1001/archpsyc.58.5.512. No abstract available.
PubMed 11343534Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
PubMed 34817851
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Antidepressants With Fatty Acid Therapy
- ClinicalTrials.gov ID
- NCT00963196
- Acronym / sponsor ID
- SADFAT / 14503
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: End of allotted time for subject recruiting.
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 21 Aug 2009 (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 be a randomized controlled trial set in an outpatient clinic, involving patients with major depressive disorder, who will be treated with antidepressant therapy, which will be individually agreed upon by the subject and his or her physician. Patients will be randomized to receive either placebo or fish oil capsules containing eicosapentaenoic acid (EHA) and docosahexaenoic acid (DHA) in addition to their antidepressant medication. Subjects will complete a brief dietary and exercise habits survey at the beginning of the trial to take into account lifestyle factors that may be significant in symptom resolution. Their progress will be monitored over a period of twelve weeks, with standardized rating scales completed by subjects and treating physicians. At the end of the study, scores will be compared between groups to look for differences in timing and degree of symptom improvement to analyze whether improvement occurred faster in the group receiving essential fatty acids (EFAs) than in the one receiving placebo. The primary hypothesis is that supplementation of antidepressant therapy with omega-3 fatty acids will decrease the lag period between the start of therapy and the time of clinically significant symptom improvement. A secondary hypothesis is that the results of this study will be consistent with numerous previous studies showing improvement in symptom control in major depressive disorder when antidepressants are supplemented with omega-3 fatty acids.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One unsuccessful trial | Active comparator | Dietary Supplement: Omega-3 fatty acid, Drug: Bovine gelatin capsulesPatients with one unsuccessful previous antidepressant trial |
| One successful trial | Active comparator | Dietary Supplement: Omega-3 fatty acid, Drug: Bovine gelatin capsulesPatients with one previous successful antidepressant trial |
| No previous trial | Active comparator | Dietary Supplement: Omega-3 fatty acid, Drug: Bovine gelatin capsulesPatients with no prior antidepressant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Major Depressive Disorder.
- Allowed comorbidities: Dysthymia, Anxiety Disorders.
- 18 years old or older.
- Males + Females.
- English-speaking.
Key exclusion criteria (15 listed)
- 2 or more failed trials of antidepressants (adequate dose and duration, and documented).
- Substance dependence in the past 6 months.
- Current substance use or abuse (MJ, benzodiazepines, narcotics). If BZD use, patient must be tapered off and wait 1 month before being included in the trial.
- Psychosis.
- Bipolar Affective Disorder Type I, II or NOS.
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 acid2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks | Dietary supplement | No previous trial, One successful trial, One unsuccessful trial |
| Bovine gelatin capsulesBovine gelatin capsules that appear similar to active drug acting as placebo. | Drug | No previous trial, One successful trial, One unsuccessful trial |
Primary outcome
Improvement in MADRS and PHQ-9 scores occurs in a shorter period of time in the intervention group versus the placebo group.
Time frame: 12 weeks
1 secondary outcome
Subjects in the intervention group experience greater reduction of scores in MADRS and PHQ-9 than the placebo group.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
- Background: PubMed 15802681Hallahan B, Garland MR. Essential fatty acids and mental health. Br J Psychiatry. 2005 Apr;186:275-7. doi: 10.1192/bjp.186.4.275. No abstract available.
- Background: PubMed 15301790Hallahan B, Garland MR. Essential fatty acids and their role in the treatment of impulsivity disorders. Prostaglandins Leukot Essent Fatty Acids. 2004 Oct;71(4):211-6. doi: 10.1016/j.plefa.2004.03.006.
- Background: PubMed 9643729Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213. doi: 10.1016/S0140-6736(05)79168-6. No abstract available.
- Background: PubMed 12091259Gesch CB, Hammond SM, Hampson SE, Eves A, Crowder MJ. Influence of supplementary vitamins, minerals and essential fatty acids on the antisocial behaviour of young adult prisoners. Randomised, placebo-controlled trial. Br J Psychiatry. 2002 Jul;181:22-8. doi: 10.1192/bjp.181.1.22.
- Background: PubMed 12821543Pischon T, Hankinson SE, Hotamisligil GS, Rifai N, Willett WC, Rimm EB. Habitual dietary intake of n-3 and n-6 fatty acids in relation to inflammatory markers among US men and women. Circulation. 2003 Jul 15;108(2):155-60. doi: 10.1161/01.CIR.0000079224.46084.C2. Epub 2003 Jun 23.
- Background: PubMed 10232294Stoll AL, Severus WE, Freeman MP, Rueter S, Zboyan HA, Diamond E, Cress KK, Marangell LB. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1999 May;56(5):407-12. doi: 10.1001/archpsyc.56.5.407.
- Background: PubMed 11343534Tanskanen A, Hibbeln JR, Hintikka J, Haatainen K, Honkalampi K, Viinamaki H. Fish consumption, depression, and suicidality in a general population. Arch Gen Psychiatry. 2001 May;58(5):512-3. doi: 10.1001/archpsyc.58.5.512. No abstract available.
- Derived from this study: PubMed 34817851Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Anita H Clayton, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acid and Bovine gelatin capsules in people with Major Depressive Disorder, run by University of Virginia 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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 4 Jun 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in MADRS and PHQ-9 scores occurs in a shorter period of time in the intervention group versus the placebo group. (time frame: 12 weeks). 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 NCT00963196, which also lists 8 linked publications.
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 4 Jun 2010.