Page 44 - e-book CPG - Bipolar Disorder
P. 44

CLINICAL PRACTICE GUIDELINES              MANAGEMENT OF BIPOLAR DISORDER (2ND ED.)




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                were consistent in a subgroup analysis of 10 - 12-year-old and 13 - 17-year-old study
                were consistent in a subgroup analysis of 10 - 12-year-old and 13 - 17-year-old study
                                             en
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                subjects with or without prior bipolar treatment
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                subjects with or without prior bipolar treatment

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                showed greater response rates with both doses (p<0.01)
                       ea
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              
                showed greater response rates with both doses (p<0.01)
                showed greater response rates with both doses (p<0.01)
                                          ce,
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            The commonly reported AEs were somnolence, headache and EPS.

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            The commonly reported AEs were somnolence, headache and EPS.  .
            The commonly reported AEs were somnolence, headache and EPS.

            In a recent RCT on 10 - 17-year-old patients with BD I in manic/mixed episodes, ziprasidone
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            In a recent RCT on 10 - 17-year-old patients with BD I in manic/mixed episodes, ziprasidone
            In a recent RCT on 10 - 17-year-old patients with BD I in manic/mixed episodes, ziprasidone

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            was more effective than placebo (MD in YMRS total score= -4.23, 95% CI -7.14 to -1.32). The
            was more effective than placebo (MD in YMRS total score= -4.23, 95% CI -7.14 to -1.32). The
                                                  e
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            common AEs were somnolence, fatigue and nausea.
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                                                2
                                               125, level I
                                               1
                                                5
                                                 ,
            common AEs were somnolence, fatigue and nausea. 125, level I
            common AEs were somnolence, fatigue and nausea. 125, level I       I
            common AEs were somnolence, fatigue and nausea.



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            A double-blinded RCT on 10 - 17-year-olds with BD I with manic/mixed episodes showed  NS
               u

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            A double-blinded RCT on 10 - 17-year-old with BD I with manic/mixed episodes showed  NS
            A double-blinded RCT on 10 - 17-year-olds with BD I with manic/mixed episodes showed  NS
                                                                       ,
            di f f erence   i n   e f f ec t i v en ess  an d   sa f ety   be t w ee n  v al proat e   E R   m on o t he r ap y   an d  pl ace bo . 1 126, level  l
                                                                         e
                                                                       6
            difference in effectiveness and safety between valproate ER monotherapy and placebo.
                                                                      2
                                                                        lev
            difference in effectiveness and safety between valproate ER monotherapy and placebo.
                                                                        126,
            difference in effectiveness and safety between valproate ER monotherapy and placebo.
                                                                      126, level

            I I
            I   level I



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            A  meta-analysis  of  three  RCTs  on  quetiapine  monotherapy  vs  placebo  in  children  and
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            A  meta-analysis  of  three  RCTs  on  quetiapine  monotherapy  vs  placebo  in  children  and
            A  meta-analysis  of  three  RCTs  on  quetiapine  monotherapy  vs  placebo  in  children  and
                                                                     2
                                                                      ,
                                                                        e
                                                                       lev
                                                                     1
                                                                      7
            adolescents with bipolar depression showed NS difference in the following outcomes: 127, level I  I
                                                                         l
            adolescents with bipolar depression showed NS difference in the following outcomes:
            adolescents with bipolar depression showed NS difference in the following outcomes: 127, level I
                                                                     127, level I
            adolescents with bipolar depression showed NS difference in the following outcomes:
                                                      G
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               
                 Children’s depression rating scale revised (CDRS-R), CGI-BP-S scores, response and
                                             C
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                 Children’s depression rating scale revised (CDRS-R), CGI-BP-S scores, response and
                 Children’s depression rating scale revised (CDRS-R), CGI-BP-S scores, response and
                 r remission rates
                  emissi
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                 remission rates
                 remission rates
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                 discontinuation rate due to AEs
                 di
                                     s
                 discontinuation rate due to AEs
                 discontinuation rate due to AEs
            B ase d on  t he   G R A D E   as sessmen t ,   al l   ou t co m e  q ua l i t i es w ere  m od era t e  t o hi g h .
            Based on the GRADE assessment, all outcome qualities were moderate to high.
            Based on the GRADE assessment, all outcome qualities were moderate to high.
            Based on the GRADE assessment, all outcome qualities were moderate to high.

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            In  an  NMA  of four  RCTs  on  10  -  18-year-old  young  persons  with  bipolar  depression, the
            In  an  NMA  of four  RCTs  on  10  -  18-year-old  young  persons  with  bipolar  depression, the
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            effectiveness  and  safety  of  AAPs  (lurasidone,  OFC  and  quetiapine)  were  compared  with
            effectiveness  and  safety  of  AAPs  (lurasidone,  OFC  and  quetiapine)  were  compared  with
                                ,
                                8
                               128, level I
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            placebo. The findings were: 1 128, level I l  I
                               2
            placebo. The findings were: 128, level I
            placebo. The findings were:
            placebo. The findings were:
                improvement in CDRS-R with lurasidone (MD = -5.70, 95% CI -8.66 to -2.76) and  OFC   OFC
                improvement in CDRS-R with lurasidone (MD = -5.70, 95% CI -8.66 to -2.76) and
                improvement in CDRS-R with lurasidone (MD = -5.70, 95% CI -8.66 to -2.76) and  OFC
                improvement in CDRS-R with lurasidone (MD = -5.70, 95% CI -8.66 to -2.76) and  OFC
                                     8



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                (MD= - 5.0, 95% CI -8.63 to -1.38) but not with quetiapine
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                (MD= - 5.0, 95% CI -8.63 to -1.38) but not with quetiapine
                (MD= - 5.0, 95% CI -8.63 to -1.38) but not with quetiapine
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                improvement in CGI-BP-S depression scores with lurasidone (MD= -0.40, 95% CI -0.68
                                          sco
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              
                improvement in CGI-BP-S depression scores with lurasidone (MD= -0.40, 95% CI -0.68
                improvement in CGI-BP-S depression scores with lurasidone (MD= -0.40, 95% CI -0.68
                 o
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                to -0.12) but not with OFC
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                improvement in CGI-BP-S overall scores with lurasidone (MD= -0.40, 95% CI -0.68 to
                                                                     -
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                                                               95


                                  ov
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                              B
                                                                   C
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                                                         =
                improvement in CGI-BP-S overall scores with lurasidone (MD= -0.40, 95% CI -0.68 to
                improvement in CGI-BP-S overall scores with lurasidone (MD= -0.40, 95% CI -0.68 to
                -
                                        ne
                -0.12) but not with OFC and quetiapine
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                -0.12) but not with OFC and quetiapine
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                 improvement in response rate with lurasidone (OR=2.64, 95% CI 1.67 to 4.01; NNT=5)
                                                  =2.
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                improvement in response rate with lurasidone (OR=2.64, 95% CI 1.67 to 4.01; NNT=5)
                improvement in response rate with lurasidone (OR=2.64, 95% CI 1.67 to 4.01; NNT=5)
                       O
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                                            N
                                          50
                and OFC (OR=2.64, 95% CI 1.43 to 4.50; NNT=6) but not with quetiapine
                and OFC (OR=2.64, 95% CI 1.43 to 4.50; NNT=6) but not with quetiapine
                                         FC
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                improvement in remission rate with OFC (OR=1.93, 95% CI 1.10 to 3.17; NNT=7) but
                                                                       )
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                improvement in remission rate with OFC (OR=1.93, 95% CI 1.10 to 3.17; NNT=7) but
                improvement in remission rate with OFC (OR=1.93, 95% CI 1.10 to 3.17; NNT=7) but
                n
                not with lurasidone and quetiapine
                      urasi
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                not with lurasidone and quetiapine
                not with lurasidone and quetiapine
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                discontinuation due to AEs, quetiapine had fewer discontinuation vs placebo (OR=0.32,  ,
                              o
              
                                 s
                discontinuation due to AEs, quetiapine had fewer discontinuation vs placebo (OR=0.32,

                discontinuation due to AEs, quetiapine had fewer discontinuation vs placebo (OR=0.32,
                95% CI 0.07 to 0.83) whereas OFC had more discontinuation vs placebo (OR=3.31,
                            .
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                95% CI 0.07 to 0.83) whereas OFC had more discontinuation vs placebo (OR=3.31,  ,
                95% CI 0.07 to 0.83) whereas OFC had more discontinuation vs placebo (OR=3.31,
                95% CI 1.08 to 8.75) and quetiapine (OR=15.08, 95% CI 2.32 to 56.84)
                95% CI 1.08 to 8.75) and quetiapine (OR=15.08, 95% CI 2.32 to 56.84)
                95% CI 1.08 to 8.75) and quetiapine (OR=15.08, 95% CI 2.32 to 56.84)
                95% CI 1.08 to 8.75) and quetiapine (OR=15.08, 95% CI 2.32 to 56.84)
                                                            O
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            Based on SUCRA rankings, lurasidone had the highest rank followed by OFC and quetiapine
                                          he
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            B
                                         t

                                                                   q
            Based on SUCRA rankings, lurasidone had the highest rank followed by OFC and quetiapine
            Based on SUCRA rankings, lurasidone had the highest rank followed by OFC and quetiapine
                                                                  l
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                                               as
                                         t
            i in  terms  of  effectiveness.  For  safety,  quetiapine  was  ranked  first  followed  by  lurasidone,  ,
                      ec
                                                                by
                   f

                                                          f
                                         i
                                                       i
                                                              ed
                                r
                                                  an
                                                                      do
                                                    k
                                                    ed
                                      q

                                                       r
                        i

                                 sa


                                          ap
                   o
                     e
                                     ,
             n
                                     y
                              Fo
                                                                   urasi
                                    t
                m
                        t


                         v
                                                        s
                                              w
                         en
                     f
                                       ue

                                                 r
                                   e
                                                            ow
              t
                           ess.
                                            ne
                                                         t
                                                                        ne
                                           i

                 s
            in  terms  of  effectiveness.  For  safety,  quetiapine  was  ranked  first  followed  by  lurasidone,
            in  terms  of  effectiveness.  For  safety,  quetiapine  was  ranked  first  followed  by  lurasidone,
            pl ace bo   an d  O FC .   G R A D E   asse ssm en t   g av e   m i x ed   q ua l i t y   on   t he   v ario us out co m es .
            placebo and OFC. GRADE assessment gave mixed quality on the various outcomes.
            placebo and OFC. GRADE assessment gave mixed quality on the various outcomes.
            placebo and OFC. GRADE assessment gave mixed quality on the various outcomes.


             R ec ommend at i on   1 1
             Recommendation 11
             Recommendation 11
             Recommendation 11
                             esc
                                     h bi
                         d adol

                       an
                                    i

                                    t
                 r
                                           di
               For children and adolescents with bipolar disorder:  :
             
                                         ar
                                       po
                                            sorde
                                         l
                                                r
                                  s
                    dren
                  chi
                                en
                    l
                                 t
                                   w

               Fo
               For children and adolescents with bipolar disorder:
               For children and adolescents with bipolar disorder:
                         i

                                                             ed

                                                                 sod
                                                                 i
                           cho
                                                               ep
                    cal
                        t
                         psy
                       an
               o  atypical antipsychotics* monotherapy may be used in manic or mixed episodes
                                  on
                                                         or
                                          m

                                                                    es


                                               u
                                           ay


                                                   n m
                                             be
                                    othe
                                                   i

                                                        c
                                 m
                   pi
                                                s
                                                            i
                              i
                                                      an
                                                 ed
                                       ap
                                                            x
                              t
                              cs
                                                           m
                                                        i

                 aty
                                *
                                         y
                                       r

               o  atypical antipsychotics* monotherapy may be used in manic or mixed episodes
               o
               o  atypical antipsychotics* monotherapy may be used in manic or mixed episodes
                                                                  d
                                                  on
                                          e
                                                 t
                                                      ay
                                                  i
                      ne
                                                na

                                                     m

                                            combi
                                                                      ssi
                                                                  ep
               o  lurasidone  and  olanzapine/fluoxetine  combination  may  be  used  in  depressive

                                                                n
                                                         be
                                                           use
                           d
                                    f
                     do

                                ap
                                                              d
                                  ne
                                  i

                                    /
                                                                    r
                 urasi
                                                               i

                                                                     e
                                                                       v
                                       etin
                         an
                                       x
                                     uo
                                     l
                             ol
                               z
                              an
                 l
                                                                        e
               o  lurasidone  and  olanzapine/fluoxetine  combination  may  be  used  in  depressive
               o
               o  lurasidone  and  olanzapine/fluoxetine  combination  may  be  used  in  depressive
                   sod
                   i
                      s
                 ep
                     e
                 episodes
                 episodes
                 episodes
                                                                    do
                                                                     ne
                   ol
                                                     r
                                                      spe
                                                     i

                                  ne
                                                  ne
                                                    ,
                                 do
                                                        r
                    e,
                                                         do
                                                        i
                            ,
             arip
                              urasi

                             l
                                            ,
                praz
               i

                                      an
                                        a
                                         pi
                                          ne
                                        z
                                                i
                                    ,
                                                  i
                                                ap
                                               t
                                     ol
                                             q
                                              ue

                           ne
                                                                 prasi


                                                               z
                                                                i
                                                          ne
                          pi
                                                             nd
            *aripiprazole, asenapine, lurasidone, olanzapine, quetiapine, risperidone and ziprasidone
                        na
                     ase
                                                             a
            *
            *aripiprazole, asenapine, lurasidone, olanzapine, quetiapine, risperidone and ziprasidone
            *aripiprazole, asenapine, lurasidone, olanzapine, quetiapine, risperidone and ziprasidone

            R ef e r   t o  A pp en dix  1 1   f o r   S ug ge sted   P a e dia t r i c  M ed i ca t i on s   D os i ng .
            Refer to Appendix 11 for Suggested Paediatric Medications Dosing.
            Refer to Appendix 11 for Suggested Paediatric Medications Dosing.
            Refer to Appendix 11 for Suggested Paediatric Medications Dosing.


            8.4.  People with Substance Use Disorder
            8.4.    P eo ple  w i t h  S ub s t an ce   U se   D i so rder
            8.4.  People with Substance Use Disorder
            8.4.  People with Substance Use Disorder


            Substance use disorder (SUD) is a common co-morbidity of BD. Substance use may cause,
            S ub st an ce  use   di sorder   ( S U D )   i s  a  co m m on   co - m orbi di t y   o f   B D .   S ub st a nce   use   m ay   cau se,
            Substance use disorder (SUD) is a common co-morbidity of BD. Substance use may cause,
            Substance use disorder (SUD) is a common co-morbidity of BD. Substance use may cause,
                                      he
                       or
                                         h
                                                                       m
                                       al

                                         t
                      e
                     i

                             i
                             cate
                   de
                     r
                           m
                            pl
                                                                        al
                                    t
                                    al
                         co
                 un
                                 m
                                  en
                     l
            m

                                                        ev
            mimic, underlie or complicate mental health disorders. Empirical evidence to guide optimal
                                                                     op
                                                     r
                                                    pi
                                                      cal
                                                     i

                                                               o
                                                               t
                                                                 ui
                                                                 g
                                                                   de
                                                          de
                                                          i

                                                            nce
               i
                                                                      t
                                               r
                                              de
                                          di
                                                                       i
               c,
                                            sor
                                                  E

                                                   m
              i
              m
                                                s.
            mimic, underlie or complicate mental health disorders. Empirical evidence to guide optimal
            mimic, underlie or complicate mental health disorders. Empirical evidence to guide optimal
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