ManiaPhase 2R34NCT00917501
Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania
A Phase 2 study testing OMega 3 in people with Mania, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical depression"). Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Mania
- What is being tested?
- OMega 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 10-21 years old.
- At least one biological parent with bipolar I disorder.
- Meets DSM-IV-TR 80 criteria for major depressive disorder (MDD or Depressive Disorder NOS at screening as determined by the Washington University at St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia, WASH-U-KSADS;81
- Childhood Depression Rating Scale-Revised Version40,41(CDRS-R) scores greater than or equal to 40 at screening and baseline.
- Fluent in English.
- Provision of written informed consent/assent as previously described.
- Agrees to use one of the following method of birth control: complete abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive.
Who cannot join
- Contraindication to an MRI scan (e.g., metal clips, braces or claustrophobia).
- Mood symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by careful medical evaluation or rapid symptom resolution.
- Psychotic symptoms (i.e., hallucinations or delusions).
- Any lifetime history of a manic or hypomanic episode.
- Any lifetime diagnosis of bipolar disorder not otherwise specified (NOS) or cyclothymia or a current diagnosis of depressive disorder NOS. A current diagnosis of dysthymia will not be exclusionary, if the adolescent also has a current diagnosis of MDD.
- A history of a major medical (e.g. diabetes) or neurological illness, laboratory abnormalities, or a significant episode (> 10 minutes) of loss of consciousness that could influence the MRS results, as determined by a study physician.
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- Any history of alcohol or drug dependence (nicotine dependence is permitted).
- Allergy to shellfish or seafood.
- Mental retardation (IQ<70) as determined by the Wechsler Abbreviated Scale of Intelligence (WASI), administered by a research coordinator who is a trained psychometrician.
- A positive serum pregnancy test or lactating.
- A history of intolerance, hypersensitivity or non-response to omega-3 fatty acids.
- Any history of a hematological disorder in themselves or a first-degree relative, since omega-3 fatty acids may be associated with anti-coagulant effects.
- Concomitant use of medications with anticoagulant effects (e.g. aspirin).
- A lithium or valproate serum level of >0.4 mEq/L and 30 mg/L, respectively at baseline.
- Use of antipsychotics, other mood stabilizers, stimulants (if opting to discontinue), or atomoxetine within 72 hours (aripiprazole within two weeks will be exclusionary because of its long half-life) or antidepressants within 5 days (fluoxetine within one month will be exclusionary because of its long half-life). Patients treated with a depot antipsychotic within one dosing interval of baseline will be excluded. Subjects diagnosed with ADHD and taking a stable dose of stimulants for the previous month will be permitted to continue if it is determined necessary by subject, primary caregiver, and treating clinician report in conjunction with the study physician.
- Concomitant use of other psychotropic medications or medications with central nervous system (CNS) effects within 5 half-lives from baseline MRI scan or prior treatment with a medication with CNS effects that requires more than 5 days of a screening period.
- Any psychiatric symptom that requires admission to an inpatient psychiatric hospital, as determined by a study physician.
- Any initiated psychotherapy within 2 months prior to the screening visit, or plans to initiate psychotherapy during study participation. Adolescents who present with their current depressive episode despite longer-term psychotherapy (i.e., >2 months) may be included. For participants who enter the study on psychotherapy, the type and frequency of therapy will remain constant during the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical depression"). Another purpose of this study is to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient more or less likely to develop mania (i.e. periods of irritability or extreme silliness accompanied by decreased need for sleep, risky behaviors, feeling like the patient has special abilities, inability to sit still, and rapid speech) in the future. Yet another purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3 fatty acids are not United States Food and Drug Administration (FDA)-approved to treat depression in adults or in children and adolescents.
Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea foods, though they are also found in other food sources such as flax seed. Omega-3 fatty acids have been shown to play a role in affecting brain chemicals responsible for regulating mood and have been found to reduce symptoms of depression in medicated-patients with major depressive disorder.
By completing this study, the investigators hope to better understand who benefits from treatment, why they do or do not respond to medications, and who is at greater risk for developing further mental illness. With this information, the investigators hope to be able to improve treatment and outcome in people with major depressive disorder.
Read the detailed description
- Specific Aims: (1) To collect pilot data regarding the efficacy, safety, and tolerability of omega-3 fatty acid supplementation for the treatment of adolescents with active depressive symptoms and a high risk for developing mania (i.e. the patient has a bipolar parent and meet DSM-IV-TR criteria for major depressive disorder). (2) To use proton magnetic resonance spectroscopy (1H MRS) (i.e. prefrontal neurochemistry) and red blood cell (RBC) omega-3 fatty acid levels to examine potential mediators of treatment response to omega-3 fatty acids in adolescents with a high risk for mania.
- Conditions
- Mania
- Being tested
- OMega 3, Placebo
- Keywords
- Mania, Adolescents at risk for Mania
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMega 3Drug
Also called Fish oil
Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA taken twice a day
PlaceboDrug
Also called Olive oil
Placebo given twice a day which will be compared to Omega 3
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo to the Omega-3 given in other group taken twice a day. Receives: Drug: Placebo |
| Omega 3 | Active comparator | Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA \& will be taken twice a day. Receives: Drug: OMega 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Depression Symptom Severity at 12 Weeks
Change in Children's Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ManiaStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Robert McNamara, University of Cincinnati
- Investigators
- Melissa DelBello, MD, Principal investigator, University of CincinnatiRobert McNamara, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917501
- Sponsor's protocol ID
- Del/McNa OMega 3
- Other IDs
- MH083924
- Acronym
- R34
- Status last verified
- Oct 2019
- First submitted
- 8 Jun 2009
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania
- ClinicalTrials.gov ID
- NCT00917501
- Acronym / sponsor ID
- R34 / Del/McNa OMega 3
- Conditions
- Mania
- Keywords
- Mania, Adolescents at risk for Mania
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- Jun 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Posted 9 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical depression"). Another purpose of this study is to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient more or less likely to develop mania (i.e. periods of irritability or extreme silliness accompanied by decreased need for sleep, risky behaviors, feeling like the patient has special abilities, inability to sit still, and rapid speech) in the future. Yet another purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3 fatty acids are not United States Food and Drug Administration (FDA)-approved to treat depression in adults or in children and adolescents.
Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea foods, though they are also found in other food sources such as flax seed. Omega-3 fatty acids have been shown to play a role in affecting brain chemicals responsible for regulating mood and have been found to reduce symptoms of depression in medicated-patients with major depressive disorder.
By completing this study, the investigators hope to better understand who benefits from treatment, why they do or do not respond to medications, and who is at greater risk for developing further mental illness. With this information, the investigators hope to be able to improve treatment and outcome in people with major depressive disorder.
Detailed description
- Specific Aims: (1) To collect pilot data regarding the efficacy, safety, and tolerability of omega-3 fatty acid supplementation for the treatment of adolescents with active depressive symptoms and a high risk for developing mania (i.e. the patient has a bipolar parent and meet DSM-IV-TR criteria for major depressive disorder). (2) To use proton magnetic resonance spectroscopy (1H MRS) (i.e. prefrontal neurochemistry) and red blood cell (RBC) omega-3 fatty acid levels to examine potential mediators of treatment response to omega-3 fatty acids in adolescents with a high risk for mania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to the Omega-3 given in other group taken twice a day. |
| Omega 3 | Active comparator | Drug: OMega 3Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA \& will be taken twice a day. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Ages 10-21 years old.
- At least one biological parent with bipolar I disorder.
- Meets DSM-IV-TR 80 criteria for major depressive disorder (MDD or Depressive Disorder NOS at screening as determined by the Washington University at St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia, WASH-U-KSADS;81
- Childhood Depression Rating Scale-Revised Version40,41(CDRS-R) scores greater than or equal to 40 at screening and baseline.
- Fluent in English.
Key exclusion criteria (18 listed)
- Contraindication to an MRI scan (e.g., metal clips, braces or claustrophobia).
- Mood symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by careful medical evaluation or rapid symptom resolution.
- Psychotic symptoms (i.e., hallucinations or delusions).
- Any lifetime history of a manic or hypomanic episode.
- Any lifetime diagnosis of bipolar disorder not otherwise specified (NOS) or cyclothymia or a current diagnosis of depressive disorder NOS. A current diagnosis of dysthymia will not be exclusionary, if the adolescent also has a current diagnosis of MDD.
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 3Also: Fish oilIndividual omega-3 capsules contain 400 mg EPA and 200 mg DHA taken twice a day | Drug | Omega 3 |
| PlaceboAlso: Olive oilPlacebo given twice a day which will be compared to Omega 3 | Drug | Placebo |
Primary outcome
Change From Baseline in Depression Symptom Severity at 12 Weeks
Time frame: Baseline and 12 weeks
Change in Children's Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Melissa DelBello, MD principal investigator
University of Cincinnati
Robert McNamara, PhD principal investigator
University of Cincinnati
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 in people with Mania, run by University of Cincinnati 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 7 inclusion and 18 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 13 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Depression Symptom Severity at 12 Weeks (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2019.