Disorders - Bipolar Disorders
Detke, H.
C., Delbello, M. P., Landry, J., Usher, R. W.
Objective To assess the
efficacy and safety of olanzapine/fluoxetine combination (OFC) for the acute treatment of bipolar depression in children and adolescents. Method
Patients 10 to 17 years of age with bipolar I disorder (BP-I), depressed episode, baseline Children's Depression Rating Scale-Revised (CDRS-R) total
score =40, Young Mania Rating Scale (YMRS) total score =15, and YMRS-item 1 =2 were randomized to OFC (6/25-12/50 mg/day olanzapine/fluoxetine; n =
170) or placebo (n = 85) for up to 8 weeks of double-blind treatment. The primary efficacy measure was mean change in CDRS-R using mixed-model
repeated-measures methodology. Results Baseline-to-week-8 least-squares mean change in CDRS-R total score was greater for OFC-treated patients than
for placebo-treated patients (-28.4 versus -23.4, p =.003; effect size =.46), with between-group differences statistically significant at week 1 (p
=.02) and all subsequent visits (all p <.01). Rates of and times to response and remission were statistically significantly greater for OFC- than for
placebo-treated patients. The most frequent treatment-emergent adverse events in the OFC group were weight gain, increased appetite, and somnolence.
Mean weight gain at patient's endpoint was significantly greater for OFC- than for placebo-treated patients (4.4 kg versus 0.5 kg, p <.001).
Treatment-emergent hyperlipidemia was very common among OFC-treated patients. Abnormal increases in hepatic analytes, prolactin, and corrected QT
interval (QTc) were also common or very common but generally not clinically significant. Conclusion In this study, OFC was superior to placebo, and
has been approved by the US Food and Drug Administration (FDA) for the acute treatment of bipolar I depression in patients 10 to 17 years of age.
Benefits should be weighed against the risk of adverse events, particularly weight gain and hyperlipidemia. Clinical trial registration information -
A Study for Assessing Treatment of Patients Ages 10-17 with Bipolar Depression; http://clinicaltrials.gov; NCT00844857.
Journal of the American Academy of Child & Adolescent Psychiatry, 54(3) : 217-
224
- Year: 2015
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Selective serotonin reuptake inhibitors (SSRIs), Atypical Antipsychotics (second
generation)
Goldstein, T. R., Fersch-Podrat, R. K., Rivera, M., Axelson, D. A., Merranko, J., Yu, H., Brent, D. A., Birmaher, B.
Objective: The purpose of this study was to conduct a pilot randomized trial of dialectical behavior therapy (DBT) versus psychosocial
treatment as usual (TAU) for adolescents diagnosed with bipolar disorder (BP). Methods: We recruited participants 12-18 years of age with a primary
BP diagnosis (I, II, or operationalized not otherwise specified [NOS] criteria) from a pediatric specialty clinic. Eligible patients were assigned
using a 2:1 randomization structure to either DBT (n=14) or psychosocial TAU (n=6). All patients received medication management from a study-
affiliated psychiatrist. DBT included 36 sessions (18 individual, 18 family skills training) over 1 year. TAU was an eclectic psychotherapy approach
consisting of psychoeducational, supportive, and cognitive behavioral techniques. An independent evaluator, blind to treatment condition, assessed
outcomes including affective symptoms, suicidal ideation and behavior, nonsuicidal self-injurious behavior, and emotional dysregulation, quarterly
over 1 year. Results: Adolescents receiving DBT attended significantly more therapy sessions over 1 year than did adolescents receiving TAU, possibly
reflecting greater engagement and retention; both treatments were rated as highly acceptable by adolescents and parents. As compared with adolescents
receiving TAU, adolescents receiving DBT demonstrated significantly less severe depressive symptoms over follow-up, and were nearly three times more
likely to demonstrate improvement in suicidal ideation. Models indicate a large effect size, for more weeks being euthymic, over follow-up among
adolescents receiving DBT. Although there were no between-group differences in manic symptoms or emotional dysregulation with treatment, adolescents
receiving DBT, but not those receiving TAU, evidenced improvement from pre- to posttreatment in both manic symptoms and emotional dysregulation.
Conclusions: DBT may offer promise as an adjunct to pharmacotherapy in the treatment of depressive symptoms and suicidal ideation for adolescents
with BP. The DBT focus on commitment to treatment may be important for the treatment of early-onset BP. Larger controlled trials are needed to
establish the efficacy of this approach, examine impact on suicidal behavior, and demonstrate cost effectiveness.
Journal of Child & Adolescent Psychopharmacology, 25(2) : 140-
149
- Year: 2015
- Problem: Bipolar Disorders, Suicide or self-harm behaviours (excluding non-suicidal self-harm), Suicide or self-harm with comorbid mental disorder
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder), At risk (indicated or selected prevention)
-
Treatment and intervention: Psychological Interventions
(any), Dialectical behavioural therapy
(DBT)
Masi,
G., Milone, A., Stawinoga, A., Veltri, S., Pisano, S.
Although a frequent co-occurrence between bipolar disorder (BD) and conduct
disorder (CD) in youth has been frequently reported, data about pharmacological management are scarce and focused on BD type I. Second generation
antipsychotics are frequently used in clinical practice, but no comparative studies are available. The aim of this exploratory study was to compare
efficacy and safety of risperidone and quetiapine in a sample of adolescents presenting a BD type II comorbid with CD. Twenty-two patients diagnosed
with a structured interview according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (male/female ratio, 12/10; mean (SD)
age 15.0 (1.4) years) were randomized in 2 treatment groups (quetiapine [n = 12] vs risperidone [n = 10]), treated with flexible doses, and followed
up for 12 weeks. Efficacy measures assessed manic symptoms, aggression, anxiety, depression, global clinical severity, and impairment. Safety
measures included body mass index, serum prolactin, extrapyramidal adverse effects, and electrocardiogram. At the end of the study, all patients
improved in all efficacy measures. Both treatments showed similar efficacy in reducing manic symptoms and aggression. Quetiapine was more effective
in improving anxiety and depressive symptoms. A change in body mass index was found, and in a post hoc analysis, it was significant only in the
risperidone group. Prolactin significantly increased only in the risperidone group. In BD type II, CD comorbidity, quetiapine, or risperidone
monotherapy may be effective and relatively safe, although the small sample size, the limited duration of the study, and the design (lack of a blind
assessments and of a placebo group) make it difficult to draw definitive conclusions.
Journal of Clinical
Psychopharmacology, 35(5) : 587-590
- Year: 2015
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation)
Kondo, D., Huber, R., Shi, X., Prescot, A., Sung, Y., Renshaw, P.
Aims: Among
persons between 10 and 24 years of age, bipolar disorder (BD) is the 4th leading cause of worldwide medical disability. The onset is prior to age 20
in ~2/3 of cases, and 71% of first episodes are depressive. Yet there are no approved treatments for adolescent bipolar depression. Validation of
biomarkers, i.e. treatment targets, would aid development of novel therapeutics. Experts recommend targeting the glutamatergic and purinergic
systems, in seeking new treatments. In line with NIMH's emphasis on Experimental Medicine study designs, the aims of this trial were: 1) To assess
uridine's \"target engagement\" with the neurochemical entity GLX (glutamate + glutamine), measured with proton-1 magnetic resonance spectroscopy
(1H-MRS); and 2) To obtain pilot uridine clinical, safety and tolerability data, for use in planning future studies. Methods: Adolescents aged 13-20
with bipolar depression were randomized to uridine 500 mg twice daily or placebo. 1H-MRS brain scans were performed at baseline, and repeated
following 6 weeks of treatment. Results: N = 24 adolescents were enrolled. At baseline, BD subjects had increased anterior cingulate cortex (ACC)
GLX, compared with healthy controls (p < 0.001). After 6 weeks of treatment, the uridine group had a lower mean Children's Depression Rating Scale-
Revised (CDRS-R) raw score compared with placebo (p = 0.05). In the uridine group, there was a trend toward correlation between change in ACC GLX and
change in CDRS-R (p = 0.09). There was also a trend toward reduced suicidal ideation in the uridine vs. placebo groups (p = 0.08). There were no
clinically significant abnormalities on serum, urine or ECG testing. Conclusions: In adolescents with bipolar depression, uridine was well-tolerated
and was associated with decreased CDRS-R scores. Five meta-analytic reviews have unanimously concluded that brain GLX is increased in BD, compared
with healthy controls and major depressive disorder. Further study of uridine is warranted, based on the suggestion it may engage this target. A
limitation of this study is small sample size. Discussion is provided, focused on the published neural effects relevant to BD that are common to
uridine, lithium and ketamine. These shared mechanisms provide added rationale for uridine as a treatment for BD.
Bipolar Disorders, 17 : 55
- Year: 2015
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Complementary & Alternative
Interventions (CAM), Vitamins and supplements
Malhi, G. S., Bassett, D., Boyce, P., Bryant, R., Fitzgerald, P. B., Fritz, K., Hopwood, M., Lyndon, B., Mulder, R., Murray, G., Porter, R., Singh, A. B.
Objectives: To provide guidance for the management of mood disorders, based on scientific
evidence supplemented by expert clinical consensus and formulate recommendations to maximise clinical salience and utility.; Methods: Articles and
information sourced from search engines including PubMed and EMBASE, MEDLINE, PsycINFO and Google Scholar were supplemented by literature known to
the mood disorders committee (MDC) (e.g., books, book chapters and government reports) and from published depression and bipolar disorder guidelines.
Information was reviewed and discussed by members of the MDC and findings were then formulated into consensus-based recommendations and clinical
guidance. The guidelines were subjected to rigorous successive consultation and external review involving: expert and clinical advisors, the public,
key stakeholders, professional bodies and specialist groups with interest in mood disorders.; Results: The Royal Australian and New Zealand College
of Psychiatrists clinical practice guidelines for mood disorders (Mood Disorders CPG) provide up-to-date guidance and advice regarding the management
of mood disorders that is informed by evidence and clinical experience. The Mood Disorders CPG is intended for clinical use by psychiatrists,
psychologists, physicians and others with an interest in mental health care.; Conclusions: The Mood Disorder CPG is the first Clinical Practice
Guideline to address both depressive and bipolar disorders. It provides up-to-date recommendations and guidance within an evidence-based framework,
supplemented by expert clinical consensus.; Mood Disorders Committee: Professor Gin Malhi (Chair), Professor Darryl Bassett, Professor Philip Boyce,
Professor Richard Bryant, Professor Paul Fitzgerald, Dr Kristina Fritz, Professor Malcolm Hopwood, Dr Bill Lyndon, Professor Roger Mulder, Professor
Greg Murray, Professor Richard Porter and Associate Professor Ajeet Singh.; International Expert Advisors: Professor Carlo Altamura, Dr Francesco
Colom, Professor Mark George, Professor Guy Goodwin, Professor Roger McIntyre, Dr Roger Ng, Professor John O'Brien, Professor Harold Sackeim,
Professor Jan Scott, Dr Nobuhiro Sugiyama, Professor Eduard Vieta, Professor Lakshmi Yatham.; Australian and New Zealand Expert Advisors: Professor
Marie-Paule Austin, Professor Michael Berk, Dr Yulisha Byrow, Professor Helen Christensen, Dr Nick De Felice, A/Professor Seetal Dodd, A/Professor
Megan Galbally, Dr Josh Geffen, Professor Philip Hazell, A/Professor David Horgan, A/Professor Felice Jacka, Professor Gordon Johnson, Professor
Anthony Jorm, Dr Jon-Paul Khoo, Professor Jayashri Kulkarni, Dr Cameron Lacey, Dr Noeline Latt, Professor Florence Levy, A/Professor Andrew Lewis,
Professor Colleen Loo, Dr Thomas Mayze, Dr Linton Meagher, Professor Philip Mitchell, Professor Daniel O'Connor, Dr Nick O'Connor, Dr Tim Outhred,
Dr Mark Rowe, Dr Narelle Shadbolt, Dr Martien Snellen, Professor John Tiller, Dr Bill Watkins, Dr Raymond Wu.; © The Royal Australian and New Zealand
College of Psychiatrists 2015.
The Australian And New Zealand Journal Of
Psychiatry, 49(12) : 1087-1206
- Year: 2015
- Problem: Bipolar Disorders
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Psychological Interventions
(any)
Masi, G., Milone, A., Veltri, S., Iuliano, R., Pfanner, C., Pisano, S.
The atypical antipsychotic quetiapine has been used
in different psychotic and non-psychotic disorders in children and adolescents in randomized clinical trials, open-label studies and chart reviews.
Most of these studies suggest that quetiapine may be a promising agent with a potential for use in young patients. The aim of this paper is to
critically review available literature on quetiapine in the treatment of children and adolescents with a variety of psychiatric disorders, including
psychotic disorders, bipolar disorders (manic and depressive episodes), conduct disorder, autism spectrum disorder, Tourette's syndrome and
personality disorders. Furthermore, we report on possible neurochemical pathways involved during treatment with quetiapine, and discuss some issues
that are clinically relevant in daily practice, such as titration strategies, safety and tolerability, and monitoring possible side effects.
Controlled studies support the short-term efficacy for treating psychosis, mania, and aggression within certain diagnostic categories. However,
although quetiapine seems well tolerated in various pediatric populations during acute and intermediate treatments, and hyper-prolactinemia and
extra-pyramidal side effects are consistently low among studies, weight gain and alterations in lipid profile need to be closely monitored.
Furthermore, the distal benefit/risk ratio during long-term treatment remains to be determined.
Pediatric Drugs, 17 : 125-140
- Year: 2015
- Problem: Bipolar Disorders, Psychosis Disorders
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder), First episode (psychosis only)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation)
Fristad, M. A., Young, A. S., Vesco, A. T., Nader, E. S., Healy, K. Z., Gardner, W., Wolfson, H. L., Arnold, L. E.
Objective: This pilot study evaluates efficacy
of omega-3 fatty acid supplementation (?3), individual family psychoeducational psychotherapy (IF-PEP), and their combination in youth with
subsyndromal bipolar disorders (bipolar disorder not otherwise specified [BP-NOS], cyclothymic disorder [CYC]). Methods: This study was a 12 week,
randomized trial of ?3 versus placebo and IF-PEP versus active monitoring (AM) using a 2 × 2 design (?3 + PEP: n = 5; ?3 + AM: n = 5; placebo + PEP:
n = 7; placebo + AM: n = 6). Twenty-three youth ages 7-14 with BP-NOS or CYC were recruited via community advertisements and clinician referrals.
Participants could be taking stable medication for attention-deficit/hyperactivity disorder and sleep aids, but no other psychotropics. Independent
evaluators assessed participants at screen, baseline, and 2, 4, 6, 9, and 12 weeks. Primary outcome measures were the Kiddie Schedule for Affective
Disorders (K-SADS) Depression (KDRS) and Mania (KMRS) Rating Scales, Children's Depression Rating Scale-Revised (CDRS-R), and Young Mania Rating
Scale (YMRS). ?3/placebo conditions were double-blind; independent evaluators were blind to psychotherapy condition. Results: Most participants (83%)
completed the 12 week trial. Side effects were uncommon and mild. Intent-to-treat analyses indicated significant improvement in depressive symptoms
(KDRS) for combined treatment relative to placebo and AM (p = 0.01, d = 1.70). Across groups, manic symptoms improved over time without significant
treatment effects. Effect of IF-PEP on child depression compared with AM was medium (d = 0.63, CDRS-R) to large (d = 1.24, KDRS). Effect of ?3 on
depression was medium (d = 0.48, KDRS). Conclusion: IF-PEP and ?3 are well tolerated and associated with improved mood symptoms among youth with BP-
NOS and CYC.
Journal of Child &
Adolescent Psychopharmacology, 25(10) : 764-774
- Year: 2015
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Complementary & Alternative
Interventions (CAM), Psychological Interventions
(any), Family therapy, Psychoeducation, Fish oil (Omega-3 fatty acids), Omega 3 fatty
acids (e.g. fish oil, flax oil)
Pathak, V., Sinha, V. K., Praharaj, S.
K.
Objective: To examine the
efficacy of adjunctive right prefrontal high-frequency repetitive transcranial magnetic stimulation (rTMS) treatment in adolescent mania patients as
compared to sham stimulation. Methods: Twenty six right handed patients aged 12-17 years diagnosed with bipolar mania were randomized to receive
daily sessions of active or sham rTMS (20 Hz, 110% of motor threshold, 20 trains, 10 s intertrain interval) over the right dorsolateral prefrontal
cortex for 10 days. Mania was rated using Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI) at baseline, and after 5th and 10th
rTMS. Results: For YMRS scores, repeated measures analysis of variance (ANOVA) showed a significant main effect (F=44.49, degree of freedom
[df]=1.2/29.29, p<0.001, Greenhouse-Geisser corrected, effect size ?2=0.65), but the interaction effect was not significant (F=0.03, df=1.2/29.29,
p=0.912, Greenhouse-Geisser corrected). For CGI-Severity, repeated measures ANOVA showed a significant main effect (F=24.49, df=1.42/34.21, p<0.001,
Greenhouse-Geisser corrected, effect size ?2=0.51), but the interaction effect was not significant (F=0.06, df=1.2/29.29, p=0.881, Greenhouse-Geisser
corrected). Conclusion: High-frequency right prefrontal rTMS was found to be ineffective as add-on to standard pharmacotherapy in adolescent
mania.
Clinical Psychopharmacology & Neuroscience, 13(3) : 245-
249
- Year: 2015
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Transcranial magnetic stimulation
(TMS)
Muneer, A.
Bipolar disorder is a chronic, recurrent condition with the usual onset during adolescence or
early adulthood. In the Diagnostic and Statistical Manual of Mental Disorders 5th edition, it is conceptualized as a spectrum disorder
usually associated with such comorbidities as anxiety disorders and substance use disorders. It is a relatively prevalent condition often complicated
by mixed episodes, rapid cycling, subsyndromal symptoms, and treatment refractoriness. In spite of carrying substantial morbidity and mortality,
effective treatments are few and far between and conventional mood stabilizers are often unsuccessful in controlling the various manifestations of
the disorder. In this scenario, second generation antipsychotics are emerging as treatments with valid efficacy in all phases of bipolar disorder.
Quetiapine is a versatile atypical antipsychotic which was first approved for the treatment of schizophrenia, but latter on the basis of controlled
studies earned United States Food and Drug Administration's approval for acute as well as maintenance treatment of this difficult to treat
condition. In this review, recently published studies in the last 10 years were examined to update the knowledge about the efficacy and safety of
quetiapine in the treatment of bipolar disorder. The medication's clinical pharmacology was first considered followed by a literature review
summarizing its uses in bipolar disorder. The conclusion was that quetiapine was efficacious in manic, mixed and depressive episodes and as a
maintenance agent with a good tolerability profile.
Clinical Psychopharmacology & Neuroscience, 13(1) : 25-
35
- Year: 2015
- Problem: Bipolar Disorders
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation)
Vallarino, M., Henry, C., Etain, B., Gehue, L. J., Macneil, C., Scott, E. M., Barbato, A., Conus, P., Hlastala, S. A., Fristad, M., Miklowitz, D. J., Scott, J.
Depression, schizophrenia, and bipolar disorder are three of the four most burdensome problems in people aged under 25
years. In psychosis and depression, psychological interventions are effective, low-risk, and high-benefit approaches for patients at high risk of
first-episode or early-onset disorders. We review the use of psychological interventions for early-stage bipolar disorder in patients aged 15-25
years. Because previous systematic reviews had struggled to identify information about this emerging sphere of research, we used evidence mapping to
help us identify the extent, distribution, and methodological quality of evidence because the gold standard approaches were only slightly informative
or appropriate. This strategy identified 29 studies in three target groups: ten studies in populations at high risk for bipolar disorder, five
studies in patients with a first episode, and 14 studies in patients with early-onset bipolar disorder. Of the 20 completed studies, eight studies
were randomised trials, but only two had sample sizes of more than 100 individuals. The main interventions used were family, cognitive behavioural,
and interpersonal therapies. Only behavioural family therapies were tested across all of our three target groups. Although the available
interventions were well adapted to the level of maturity and social environment of young people, few interventions target specific developmental
psychological or physiological processes (eg, ruminative response style or delayed sleep phase), or offer detailed strategies for the management of
substance use or physical health.
Lancet Psychiatry, 2(6) : 548-563
- Year: 2015
- Problem: Bipolar Disorders
- Type: Systematic reviews
-
Stage: At risk (indicated or selected prevention), Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions
(any)
Salpekar, J. A., Joshi, P. T., Axelson, D. A., Reinblatt, S. P., Yenokyan, G., Sanyal, A., Walkup, J. T., Vitiello,
B., Luby, J. L., Wagner, K. D., Nusrat, N., Riddle, M. A.
Objective: To assess the efficacy of mood-stabilizing medications for depression and
suicidality in pediatric bipolar disorder. Method: The Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized, masked
comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. A total of 279 children
and adolescents with DSM-IV diagnoses of bipolar I disorder, mixed or manic, aged 6 to 15 years were enrolled. The primary outcome measure was
improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression
Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random
intercept both for the complete data set and by using last observation carried forward. Results: CGI-BP-I-D ratings were better in the RISP group
(60.7%) as compared to the LI (42.2%; p = .03) or VAL (35.0%; p = .003) groups from baseline to the end of the study. CDRS scores in all treatment
groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95% CI = 2.67, 6.78), and compared to LI
(mean = 3.63, 95% CI = 1.51, 5.74), although group differences were not present by the end of the study. Suicidality was infrequent, and there was no
overall effect of treatment on suicidality ratings. Conclusion: Depressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar
disorder, improved with all 3 medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global
categorical outcome. (PsycINFO Database Record (c) 2016 APA, all rights reserved) (journal abstract).
Journal of the American Academy of Child & Adolescent Psychiatry, 54(12) : 999-
1007
- Year: 2015
- Problem: Bipolar Disorders, Suicide or self-harm behaviours (excluding non-suicidal self-harm), Suicide or self-harm with comorbid mental disorder
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation), Anticonvulsants/mood stabilisers (excl. lithium), Lithium
Sharpley, A. L., Hockney, R., McPeake, L., Geddes, J. R., Cowen, P. J.
Background Clinical mood disorders often become clinically manifest in the later teenage years and early
twenties and can be associated with a poor long-term prognosis. The primary prevention of these disorders would therefore have great public health
value. Nutritional supplements are a feasible intervention for primary prevention and several epidemiological studies have indicated links between
low folate status and depressive symptomatology in the general population. Method A randomised, double blind, parallel group, placebo-controlled
trial in which participants, aged 14-24 years, at increased familial risk of mood disorder, were randomised to folic acid (2.5 mg daily) or identical
placebo liquid for a maximum of 36 months. Primary outcome data (the onset of a DSM-IV mood disorder) were collected from 112 participants; 56 per
group. Results The incidence of mood disorder in the folic acid and placebo groups were 14.3% and 17.9% respectively, a non-significant difference.
However, there was post-hoc evidence that folic acid delayed the time to onset of mood disorder in those participants who became unwell. Limitations
Small sample size and rate of onset of mood disorders lower than expected. Conclusions Although long term folic acid supplementation was well
tolerated, with high levels of adherence, there was no evidence that it reduced the incidence of mood disorder compared to those taking placebo.
(copyright) 2014 Elsevier B.V.
Journal of Affective Disorders, 167 : 306-311
- Year: 2014
- Problem: Bipolar Disorders, Depressive Disorders
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Complementary & Alternative
Interventions (CAM), Vitamins and supplements