Omega-3 and Therapy Study for Childhood Bipolar Disorder- Not Otherwise Specified
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 7 - 14 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | September 2014 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
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