Bipolar DisorderPhase 1OATSNCT01507753
Omega-3 and Therapy Study for Childhood Bipolar Disorder- Not Otherwise Specified
A Phase 1 study testing Omega-3 Supplementation and Psychoeducational Psychotherapy (PEP) in people with Bipolar Disorder, run by L. Eugene Arnold at 1 site in United States.
Trial summary
Childhood bipolar disorder- not otherwise specified (BP-NOS) was originally considered to be a milder version of bipolar disorder (BD). Research now indicates that BP-NOS is a highly impairing condition. No pharmacologic treatment guidelines exist for BP-NOS. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Omega-3 Supplementation and Psychoeducational Psychotherapy (PEP)
- 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
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2014
- Phase
- Phase 1
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 7-14 years (boys and girls)
- Has a diagnosis of BP-NOS according to the LAMS definition. Criteria as follows:
- Clinically significant bipolar symptoms that do not meet DSM IV TR criteria for bipolar disorder I or bipolar disorder II
- Elated mood plus 2 or more associated symptoms from DSM IV TR or irritable mood plus 3 or more symptoms
- A change in functioning, and a minimum duration of 4 hours within a 24-hour period and at least 4 cumulative lifetime days meeting criteria
- Full scale IQ ≥ 70
Show all 9Show fewer
- Child and one parent or other caregiver must be able to complete all assessment
- Child must be able to swallow capsules (training in swallowing will be offered)
- Parent and child must be willing to have blood drawn from child at two study assessments.
Who cannot join
- Major medical disorders (eg diabetes, epilepsy, metabolic disorder)
- Inability to communicate in English
- Lack of access via phone
- Autism
- Schizophrenia, or other psychotic states warranting anti-psychotic medication
- Active suicidal concern (e.g., "I want to kill myself", a plan for suicide, or an attempt in the past month; however, passive suicidal ideation, such as "I wish I were dead" would not exclude)
- Three or more symptoms rated as "marked" or "severe" on the KDRS or KMRS
- Concurrent mental health intervention (pharmacotherapy and/or psychotherapy) in the past month.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center- Harding Hospital
Columbus, Ohio, 43210
About this study
Official title: Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Bipolar Disorder- Not Otherwise Specified
Childhood bipolar disorder- not otherwise specified (BP-NOS) was originally considered to be a milder version of bipolar disorder (BD). Research now indicates that BP-NOS is a highly impairing condition. No pharmacologic treatment guidelines exist for BP-NOS. Available evidence-based pharmacotherapy guidelines are for BP1; efficacious medications are, unfortunately, associated with significant risk for adverse events (Kowatch et al, 2005; 2009). Previous research on diet and nutrition suggests that omega-3 (Ω3) fatty acids have a beneficial effect on mood, which might provide either a primary or adjunctive treatment with a more favorable risk:benefit ratio for children suffering from BP-NOS than currently available pharmacologic interventions. Psychoeducational psychotherapy (PEP) also has shown promise in treating bipolar spectrum disorders in children aged 8-12 (Fristad, 2006; Fristad, Verducci, Walters, \& Young, 2009); its efficacy in treating BP-NOS specifically has not been determined.
The current study compares Ω3, PEP, and their combination to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with BP-NOS (15 each with Ω3, Ω3 plus PEP, PEP, and placebo, all with active monitoring). Primary goals are to determine: 1) feasibility of a) recruiting 60 participants in 2 years; b) participant retention over a 12-week trial; and 2) placebo-controlled effect sizes for Ω3, PEP, and combination treatment on manic and depressive symptoms. Secondary goals are to explore response curves over time, mediators and moderators, treatment response across a broad array of outcome variables, adherence to treatment, impact on physiologic parameters often worsened by mood stabilizing medications, and experience of side-effects in participants receiving Ω3 and/or PEP. Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained. This pilot study of Ω3, PEP, and combined treatment will provide evidence about whether a larger trial is feasible and justified.
Read the detailed description
Research indicates BP-NOS is a highly impairing condition comparable to the other bipolar spectrum disorders. Considerable gains have been made recently in understanding BP-NOS, in large part by research utilizing clear operational definitions for BP-NOS. However, clinical trials have focused on youth with Bipolar Disorder- Type I (BP1). No clinical guidelines exist for the treatment of BP-NOS.
No pharmacologic treatment guidelines exist for BP-NOS. Available evidence-based pharmacotherapy guidelines are for BP1 and are associated with significant risk for adverse events. Additionally, while anti-manic agents have been identified, no study has demonstrated an effective anti-depressant agent for youth with bipolar depression. A review of weight gain and metabolic side effects of mood stabilizers and antipsychotic medications in 19 studies of pediatric bipolar patients found significant and clinically relevant weight increases in 18 trials. Clinical trials of depression and bipolar disorders in children and adolescents show approximately 20%-25% of participants dropped out of short-term psychotropic medication treatment trials. Additionally, a recent study of an anticonvulsant mood stabilizer in children failed to show any superiority to placebo.
Previous research on diet and nutrition suggests that omega-3 (Ω3) fatty acids have a beneficial effect on mood with little evidence of negative side-effects or deleterious drug interactions, suggesting Ω3 might function as either a primary or adjunctive treatment with a more favorable risk-benefit ratio for children suffering from BP than currently available pharmacologic interventions.Psychoeducational psychotherapy (PEP) also has shown promise in treating bipolar spectrum disorders in children aged 8-12 its efficacy in treating BP-NOS specifically has not been determined.
The current study compares Ω3, PEP, and their combination to a placebo supplement, all with active monitoring (AM) in a 12-week trial of 60 children with BP-NOS (15 each with Ω3, Ω3 plus PEP, PEP, and placebo. Primary goals are to determine: 1) feasibility of a) recruiting 60 participants in 2 years; b) participant retention over a 12-week trial; and 2) placebo-controlled effect sizes for Ω3, PEP, and combination treatment on manic and depressive symptoms. Secondary goals are to explore response curves over time, mediators and moderators, treatment response across a broad array of outcome variables, adherence to treatment, impact on physiologic parameters often worsened by mood stabilizing medications, and experience of side-effects in participants receiving Ω3 and/or PEP. Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained. This pilot study of Ω3, PEP, and combined treatment will provide evidence about whether a larger trial is feasible and justified.
- Conditions
- Bipolar Disorder
- Being tested
- Omega-3 Supplementation, Psychoeducational Psychotherapy (PEP), Placebo
- Keywords
- childhood bipolar disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 SupplementationDrug
Also called Omega Brite
The Ω3 group will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3) two times daily for a total daily dose of 2000 mg Ω3 (1400 mg EPA: 200 mg DHA; 400 other Ω3). The placebo group will receive two capsules two times daily matched for odor and appearance with the active intervention.
Psychoeducational Psychotherapy (PEP)Behavioural
Also called IF-PEP
Therapy sessions occur twice a week for up to 24 sessions of manualized treatment. The importance of separating symptoms from the individual is emphasized. The family is offered support, validation, and recognition for their own difficult experiences in living with the child's mood disorder. Family members are taught that patients are particularly vulnerable to stress and tension; thus, therapists work with families to reduce the level of stress and tension in their homes. Improvement of communication, problem solving and coping strategies can lead to restoration of hope for recovery and decrease family dysfunction. Goals include strengthening the parent-child bond and helping children and parents feel competent to manage depression now and in future recurrences.
PlaceboOther
Also called Pbo
The placebo group will receive active monitoring (no IF-PEP) and two capsules two times daily matched for odor and appearance with the active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Supplement and No PEP | Placebo comparator | Will receive two capsules by mouth, two times daily matched for odor and appearance with the active intervention. Receives: Other: Placebo |
| Omega-3 and PEP | Experimental | Omega-3 Supplementation will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3)by mouth, two times daily.
Psychoeducational Psychotherapy (PEP)Therapy sessions occur twice a week for up to 24 sessions of manualized treatment. Receives: Drug: Omega-3 Supplementation; Behavioral: Psychoeducational Psychotherapy (PEP) |
| Omega-3 and No PEP | Experimental | Omega-3 Supplementation will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3)by mouth, two times daily. Receives: Drug: Omega-3 Supplementation |
| Placebo Supplement and PEP | Experimental | Placebo Supplement will receive two capsules by mouth, two times daily matched for odor and appearance with the active intervention.
Psychoeducational Psychotherapy (PEP)Therapy sessions occur twice a week for up to 24 sessions of manualized treatment. Receives: Behavioral: Psychoeducational Psychotherapy (PEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to K-SADS Mania Rating Scale (KMRS)
This semi-structured interview contains 21 items that assess the severity of manic symptoms in children and adolescents. The KMRS shows high internal consistency (α = 0.94), sensitivity (0.87), and specificity (0.81) (Axelson et al., 2003). The KMRS will be administered at the assessment visits to determine worst lifetime and current (past two weeks) symptoms of mania.
Measured: Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization
Secondary outcomes (1)
Changes to K-SADS Depression Rating Scale (KDRS)
Depressive symptom severity for worst past episode(s) and current episode (past two weeks) will be assessed using the KDRS at the assessment visits. The KDRS is a 12-item semi-structured interview with depression symptoms rated on a 6-point scale from none to severe. The KDRS has been shown to be a reliable measure of symptom severity.
Measured: Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- L. Eugene Arnold
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, L. Eugene Arnold, Ohio State University
- Investigators
- L. Eugene Arnold, MD, MEd, Principal investigator, Ohio State UniversityMary A Fristad, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507753
- Sponsor's protocol ID
- 2011H0104
- Other IDs
- 1R34MH090148-01A1
- Acronym
- OATS
- Status last verified
- Mar 2016
- First submitted
- 12 Aug 2011
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vesco AT, Young AS, Arnold LE, Fristad MA. Omega-3 supplementation associated with improved parent-rated executive function in youth with mood disorders: secondary analyses of the omega 3 and therapy (OATS) trials. J Child Psychol Psychiatry. 2018 Jun;59(6):628-636. doi: 10.1111/jcpp.12830. Epub 2017 Oct 24.
PubMed 29063592Christian LM, Young AS, Mitchell AM, Belury MA, Gracious BL, Arnold LE, Fristad MA. Body weight affects omega-3 polyunsaturated fatty acid (PUFA) accumulation in youth following supplementation in post-hoc analyses of a randomized controlled trial. PLoS One. 2017 Apr 5;12(4):e0173087. doi: 10.1371/journal.pone.0173087. eCollection 2017.
PubMed 28379964Fristad MA, Young AS, Vesco AT, Nader ES, Healy KZ, Gardner W, Wolfson HL, Arnold LE. A Randomized Controlled Trial of Individual Family Psychoeducational Psychotherapy and Omega-3 Fatty Acids in Youth with Subsyndromal Bipolar Disorder. J Child Adolesc Psychopharmacol. 2015 Dec;25(10):764-74. doi: 10.1089/cap.2015.0132.
PubMed 26682997
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Bipolar Disorder- Not Otherwise Specified
- ClinicalTrials.gov ID
- NCT01507753
- Acronym / sponsor ID
- OATS / 2011H0104
- Conditions
- Bipolar Disorder
- Keywords
- childhood bipolar disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- L. Eugene ArnoldUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Jan 2012 (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.
Childhood bipolar disorder- not otherwise specified (BP-NOS) was originally considered to be a milder version of bipolar disorder (BD). Research now indicates that BP-NOS is a highly impairing condition. No pharmacologic treatment guidelines exist for BP-NOS. Available evidence-based pharmacotherapy guidelines are for BP1; efficacious medications are, unfortunately, associated with significant risk for adverse events (Kowatch et al, 2005; 2009). Previous research on diet and nutrition suggests that omega-3 (Ω3) fatty acids have a beneficial effect on mood, which might provide either a primary or adjunctive treatment with a more favorable risk:benefit ratio for children suffering from BP-NOS than currently available pharmacologic interventions. Psychoeducational psychotherapy (PEP) also has shown promise in treating bipolar spectrum disorders in children aged 8-12 (Fristad, 2006; Fristad, Verducci, Walters, \& Young, 2009); its efficacy in treating BP-NOS specifically has not been determined.
The current study compares Ω3, PEP, and their combination to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with BP-NOS (15 each with Ω3, Ω3 plus PEP, PEP, and placebo, all with active monitoring). Primary goals are to determine: 1) feasibility of a) recruiting 60 participants in 2 years; b) participant retention over a 12-week trial; and 2) placebo-controlled effect sizes for Ω3, PEP, and combination treatment on manic and depressive symptoms. Secondary goals are to explore response curves over time, mediators and moderators, treatment response across a broad array of outcome variables, adherence to treatment, impact on physiologic parameters often worsened by mood stabilizing medications, and experience of side-effects in participants receiving Ω3 and/or PEP. Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained. This pilot study of Ω3, PEP, and combined treatment will provide evidence about whether a larger trial is feasible and justified.
Detailed description
Research indicates BP-NOS is a highly impairing condition comparable to the other bipolar spectrum disorders. Considerable gains have been made recently in understanding BP-NOS, in large part by research utilizing clear operational definitions for BP-NOS. However, clinical trials have focused on youth with Bipolar Disorder- Type I (BP1). No clinical guidelines exist for the treatment of BP-NOS.
No pharmacologic treatment guidelines exist for BP-NOS. Available evidence-based pharmacotherapy guidelines are for BP1 and are associated with significant risk for adverse events. Additionally, while anti-manic agents have been identified, no study has demonstrated an effective anti-depressant agent for youth with bipolar depression. A review of weight gain and metabolic side effects of mood stabilizers and antipsychotic medications in 19 studies of pediatric bipolar patients found significant and clinically relevant weight increases in 18 trials. Clinical trials of depression and bipolar disorders in children and adolescents show approximately 20%-25% of participants dropped out of short-term psychotropic medication treatment trials. Additionally, a recent study of an anticonvulsant mood stabilizer in children failed to show any superiority to placebo.
Previous research on diet and nutrition suggests that omega-3 (Ω3) fatty acids have a beneficial effect on mood with little evidence of negative side-effects or deleterious drug interactions, suggesting Ω3 might function as either a primary or adjunctive treatment with a more favorable risk-benefit ratio for children suffering from BP than currently available pharmacologic interventions.Psychoeducational psychotherapy (PEP) also has shown promise in treating bipolar spectrum disorders in children aged 8-12 its efficacy in treating BP-NOS specifically has not been determined.
The current study compares Ω3, PEP, and their combination to a placebo supplement, all with active monitoring (AM) in a 12-week trial of 60 children with BP-NOS (15 each with Ω3, Ω3 plus PEP, PEP, and placebo. Primary goals are to determine: 1) feasibility of a) recruiting 60 participants in 2 years; b) participant retention over a 12-week trial; and 2) placebo-controlled effect sizes for Ω3, PEP, and combination treatment on manic and depressive symptoms. Secondary goals are to explore response curves over time, mediators and moderators, treatment response across a broad array of outcome variables, adherence to treatment, impact on physiologic parameters often worsened by mood stabilizing medications, and experience of side-effects in participants receiving Ω3 and/or PEP. Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained. This pilot study of Ω3, PEP, and combined treatment will provide evidence about whether a larger trial is feasible and justified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Supplement and No PEP | Placebo comparator | Other: PlaceboWill receive two capsules by mouth, two times daily matched for odor and appearance with the active intervention. |
| Omega-3 and PEP | Experimental | Drug: Omega-3 Supplementation, Behavioral: Psychoeducational Psychotherapy (PEP)Omega-3 Supplementation will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3)by mouth, two times daily. Psychoeducational Psychotherapy (PEP)Therapy sessions occur twice a week for up to 24 sessions of manualized treatment. |
| Omega-3 and No PEP | Experimental | Drug: Omega-3 SupplementationOmega-3 Supplementation will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3)by mouth, two times daily. |
| Placebo Supplement and PEP | Experimental | Behavioral: Psychoeducational Psychotherapy (PEP)Placebo Supplement will receive two capsules by mouth, two times daily matched for odor and appearance with the active intervention. Psychoeducational Psychotherapy (PEP)Therapy sessions occur twice a week for up to 24 sessions of manualized treatment. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Aged 7-14 years (boys and girls)
- Has a diagnosis of BP-NOS according to the LAMS definition. Criteria as follows:
- Clinically significant bipolar symptoms that do not meet DSM IV TR criteria for bipolar disorder I or bipolar disorder II
- Elated mood plus 2 or more associated symptoms from DSM IV TR or irritable mood plus 3 or more symptoms
- A change in functioning, and a minimum duration of 4 hours within a 24-hour period and at least 4 cumulative lifetime days meeting criteria
Key exclusion criteria (8 listed)
- Major medical disorders (eg diabetes, epilepsy, metabolic disorder)
- Inability to communicate in English
- Lack of access via phone
- Autism
- Schizophrenia, or other psychotic states warranting anti-psychotic medication
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 SupplementationAlso: Omega BriteThe Ω3 group will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3) two times daily for a total daily dose of 2000 mg Ω3 (1400 mg EPA: 200 mg DHA; 400 other Ω3). The placebo group will receive two capsules two times daily matched for odor and appearance with the active intervention. | Drug | Omega-3 and No PEP, Omega-3 and PEP |
| Psychoeducational Psychotherapy (PEP)Also: IF-PEPTherapy sessions occur twice a week for up to 24 sessions of manualized treatment. The importance of separating symptoms from the individual is emphasized. The family is offered support, validation, and recognition for their own difficult experiences in living with the child's mood disorder. Family members are taught that patients are particularly vulnerable to stress and tension; thus, therapists work with families to reduce the level of stress and tension in their homes. Improvement of communication, problem solving and coping strategies can lead to restoration of hope for recovery and decrease family dysfunction. Goals include strengthening the parent-child bond and helping children and parents feel competent to manage depression now and in future recurrences. | Behavioural | Omega-3 and PEP, Placebo Supplement and PEP |
| PlaceboAlso: PboThe placebo group will receive active monitoring (no IF-PEP) and two capsules two times daily matched for odor and appearance with the active intervention. | Other | Placebo Supplement and No PEP |
Primary outcome
Changes to K-SADS Mania Rating Scale (KMRS)
Time frame: Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization
This semi-structured interview contains 21 items that assess the severity of manic symptoms in children and adolescents. The KMRS shows high internal consistency (α = 0.94), sensitivity (0.87), and specificity (0.81) (Axelson et al., 2003). The KMRS will be administered at the assessment visits to determine worst lifetime and current (past two weeks) symptoms of mania.
1 secondary outcome
Changes to K-SADS Depression Rating Scale (KDRS)
Time frame: Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post randomization
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 8 Mar 2016.
- Derived from this study: PubMed 29063592Vesco AT, Young AS, Arnold LE, Fristad MA. Omega-3 supplementation associated with improved parent-rated executive function in youth with mood disorders: secondary analyses of the omega 3 and therapy (OATS) trials. J Child Psychol Psychiatry. 2018 Jun;59(6):628-636. doi: 10.1111/jcpp.12830. Epub 2017 Oct 24.
- Derived from this study: PubMed 28379964Christian LM, Young AS, Mitchell AM, Belury MA, Gracious BL, Arnold LE, Fristad MA. Body weight affects omega-3 polyunsaturated fatty acid (PUFA) accumulation in youth following supplementation in post-hoc analyses of a randomized controlled trial. PLoS One. 2017 Apr 5;12(4):e0173087. doi: 10.1371/journal.pone.0173087. eCollection 2017.
- Derived from this study: PubMed 26682997Fristad MA, Young AS, Vesco AT, Nader ES, Healy KZ, Gardner W, Wolfson HL, Arnold LE. A Randomized Controlled Trial of Individual Family Psychoeducational Psychotherapy and Omega-3 Fatty Acids in Youth with Subsyndromal Bipolar Disorder. J Child Adolesc Psychopharmacol. 2015 Dec;25(10):764-74. doi: 10.1089/cap.2015.0132.
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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.
L. Eugene Arnold, MD, MEd principal investigator
Ohio State University
Mary A Fristad, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega-3 Supplementation and Psychoeducational Psychotherapy (PEP) in people with Bipolar Disorder, run by L. Eugene Arnold 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 9 inclusion and 8 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 8 Mar 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Changes to K-SADS Mania Rating Scale (KMRS) (time frame: Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization). 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 NCT01507753, which also lists 3 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 8 Mar 2016.