Bipolar Youth Treated With Second-generation AntipsychoticsPhase 3NCT01858948
SGA-induced Metabolic Syndrome in Bipolar Youth
A Phase 3 study testing Omega and Quetiapine fumarate in people with Bipolar Youth Treated With Second-generation Antipsychotics, run by University of Cincinnati at 1 site in United States.
Trial summary
The investigators tested the hypothesis that long-chain omega-3 (LCn-3) fatty acid supplementation will attenuate the adverse cardiometabolic effects of second-generation antipsychotics exposure in first-episode adolescent manic patients. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar Youth Treated With Second-generation Antipsychotics
- What is being tested?
- Omega and Quetiapine fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Apr 2018
- Phase
- Phase 3
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV-TR criteria for bipolar disorder, type I, manic or mixed episode
- Baseline YMRS score > 20
- Ages 10-17 years
- Tanner scale stages III-V
- No prior exposure to SGA medications
- Fluent in English
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- Provision of written informed consent by a legal guardian and written assent by the subject
- Manic or depressive symptoms do not result entirely from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation and rapid symptom resolution
- If female and of child bearing potential, agrees to use one of the following method of birth control: complete abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive. For Phase II, additional Inclusion criteria are
- Receiving a stable therapeutic dose of quetiapine for a minimum of 1 week (i.e., patients who achieved remission (YMRS total score 7 during Phase I)
- Not requiring concomitant use of antidepressant or mood-stabilizer medications (see Section C.4.c. Concomitant Medications).
Who cannot join
- IQ < 70, as determined by The Wechsler Abbreviated Scale of Intelligence
- Positive pregnancy test (to avoid teratogenesis)
- A history of major cardiovascular or neurological illness
- Any lifetime DSM-IV-TR substance use disorder (nicotine dependence is permitted)
- A lifetime DSM-IV-TR diagnosis of any pervasive developmental disorder
- Any history of a hematological disorder in themselves or a first-degree relative will be excluded (since omega-3 fatty acids may be associated with anti-thrombotic effects). Similarly, concomitant use of medications with anticoagulant effects (e.g. aspirin) will be prohibited
- Allergy to fish/seafood; 8) Currently taking omega-3 fatty acid supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth
The investigators tested the hypothesis that long-chain omega-3 (LCn-3) fatty acid supplementation will attenuate the adverse cardiometabolic effects of second-generation antipsychotics exposure in first-episode adolescent manic patients.
Read the detailed description
Following acute (6-week) open-label treatment with quetiapine, first-episode adolescent manic patients (ages 10-17 years) were randomized to double-blind adjunctive treatment with long-chain omega-3 (LCn-3) fatty acids or placebo for 24 weeks to investigate protective effects on the of adverse cardiometabolic events and weight gain during quetiapine maintenance therapy. They will have 6 visits over a 24-week period.
- Being tested
- Omega, Placebo, Quetiapine fumarate
- Keywords
- Bipolar disorder, Second-generation antipsychotics, Obesity, Cardiometabolic risk
- Medical subject headings
- Bipolar Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegaDrug
Also called EPA+DHA supplements (OmegaRx)
Omega-3 supplements
PlaceboDrug
Also called Placebo supplements (corn oil) provided by the Inflammation Research Foundation
Similar in shape and color to Omega supplements
Quetiapine fumarateDrug
Also called Seroquel
Prior to randomization to Omega/placebo, patients were started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine plus Omega | Experimental | Patients will be randomized to EPA+DHA supplements (OmegaRx) at fixed dose of 3.0 g/day (EPA: 2.0 g, DHA: 1.0 g; 5 capsules/d) for 24 weeks. Receives: Drug: Omega; Drug: Quetiapine fumarate |
| Quetiapine plus Placebo | Placebo comparator | Patients will be randomized to similar in shape an color placebo supplements (corn oil) Receives: Drug: Placebo; Drug: Quetiapine fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Body Mass Index (BMI) is a measure of body fat calculated as weight in kilograms divided by height in meters squared (kg/m^2). BMI Categories are:
Underweight = <18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater. Greater decreases in BMI are a better outcome.
Measured: 24 weeks
Fasting Blood Triglycerides Levels
Triglycerides are the chemical form in which most fat exists in food as well as in the body. They're also present in blood plasma and, in association with cholesterol, form the plasma lipids. Levels are categorized as follows: Normal - Less than 150 milligrams per deciliter (mg/dL); Borderline high - 150 to 199 mg/dL; High - 200 to 499 mg/dL; Very high - 500 mg/dL or above. Greater reductions blood triglyceride levels are a better outcome.
Measured: 24 weeks
Secondary outcomes (1)
Manic Symptom Severity
Manic symptom ratings will be obtained using the Young Mania Rating Scale (YMRS). The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania: Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). Greater reductions from baseline indicates a greater improvement in manic symptoms.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2018
- Study completionApr 2018
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 Bipolar Youth Treated With Second-generation AntipsychoticsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert McNamara, University of Cincinnati
- Investigators
- Robert K McNamara, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858948
- Sponsor's protocol ID
- DK097599-01A1
- Other IDs
- 5R01DK097599
- Status last verified
- Nov 2022
- First submitted
- 16 May 2013
- Last updated
- 25 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth
- ClinicalTrials.gov ID
- NCT01858948
- Acronym / sponsor ID
- DK097599-01A1
- Keywords
- Bipolar disorder, Second-generation antipsychotics, Obesity, Cardiometabolic risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2013
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Posted 25 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators tested the hypothesis that long-chain omega-3 (LCn-3) fatty acid supplementation will attenuate the adverse cardiometabolic effects of second-generation antipsychotics exposure in first-episode adolescent manic patients.
Detailed description
Following acute (6-week) open-label treatment with quetiapine, first-episode adolescent manic patients (ages 10-17 years) were randomized to double-blind adjunctive treatment with long-chain omega-3 (LCn-3) fatty acids or placebo for 24 weeks to investigate protective effects on the of adverse cardiometabolic events and weight gain during quetiapine maintenance therapy. They will have 6 visits over a 24-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine plus Omega | Experimental | Drug: Omega, Drug: Quetiapine fumaratePatients will be randomized to EPA+DHA supplements (OmegaRx) at fixed dose of 3.0 g/day (EPA: 2.0 g, DHA: 1.0 g; 5 capsules/d) for 24 weeks. |
| Quetiapine plus Placebo | Placebo comparator | Drug: Placebo, Drug: Quetiapine fumaratePatients will be randomized to similar in shape an color placebo supplements (corn oil) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- DSM-IV-TR criteria for bipolar disorder, type I, manic or mixed episode
- Baseline YMRS score > 20
- Ages 10-17 years
- Tanner scale stages III-V
- No prior exposure to SGA medications
Key exclusion criteria (7 listed)
- IQ < 70, as determined by The Wechsler Abbreviated Scale of Intelligence
- Positive pregnancy test (to avoid teratogenesis)
- A history of major cardiovascular or neurological illness
- Any lifetime DSM-IV-TR substance use disorder (nicotine dependence is permitted)
- A lifetime DSM-IV-TR diagnosis of any pervasive developmental disorder
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 |
|---|---|---|
| OmegaAlso: EPA+DHA supplements (OmegaRx)Omega-3 supplements | Drug | Quetiapine plus Omega |
| PlaceboAlso: Placebo supplements (corn oil) provided by the Inflammation Research FoundationSimilar in shape and color to Omega supplements | Drug | Quetiapine plus Placebo |
| Quetiapine fumarateAlso: SeroquelPrior to randomization to Omega/placebo, patients were started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg. | Drug | Quetiapine plus Omega, Quetiapine plus Placebo |
Primary outcome
Body Mass Index (BMI)
Time frame: 24 weeks
Body Mass Index (BMI) is a measure of body fat calculated as weight in kilograms divided by height in meters squared (kg/m^2). BMI Categories are: Underweight = <18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater. Greater decreases in BMI are a better outcome.
Fasting Blood Triglycerides Levels
Time frame: 24 weeks
Triglycerides are the chemical form in which most fat exists in food as well as in the body. They're also present in blood plasma and, in association with cholesterol, form the plasma lipids. Levels are categorized as follows: Normal - Less than 150 milligrams per deciliter (mg/dL); Borderline high - 150 to 199 mg/dL; High - 200 to 499 mg/dL; Very high - 500 mg/dL or above. Greater reductions blood triglyceride levels are a better outcome.
1 secondary outcome
Manic Symptom Severity
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Robert K 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 3 study testing Omega and Quetiapine fumarate in people with Bipolar Youth Treated With Second-generation Antipsychotics, 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 11 inclusion and 7 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 25 Nov 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Nov 2022). 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?
Body Mass Index (BMI) (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 25 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.