Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment

British Medical Journal, Jan 16, 1999 by Alison Perry, Nicholas Tarrier, Richard Morriss, Eilis McCarthy, Kate Limb

(*) Recurrent mania requiring admission together with major depression.

([dagger]) Recurrent major depression with occasional hypomania not requiring admission

([double dagger]) Obsessive compulsive disorder (n=4), social phobia (n=3), generalised anxiety disorder (n=2), anxiety disorder not otherwise specified (n=2), simple phobia (n=2).

[Figure 1 ILLUSTRATION OMITTED]

The median number of experimental sessions lasting one hour each was nine (range 0-12). The completed experimental treatment was between seven and 12 sessions of one hour each (median 9, range 0-12). The variation occurred because patients who had only manic relapses had fewer sessions, patients who had relapses during treatment had extra revision sessions, and some patients took longer to identify prodromal symptoms. Seven patients were allocated to the experimental treatment but did not complete it, five because of time commitments (two had no sessions, two one session, and one three sessions), one because she became pregnant and stopped attending (five sessions), and one because she became depressed and did not find the sessions helpful (six sessions).

Figure 2 shows that the 25th centile time to first manic relapse was 65 weeks in the experimental group and 17 weeks in the control group. In contrast, figure 3 shows that the 25th centile time to first depressive relapse was 21 weeks in the experimental group and 26 weeks in the control group. The event curves for the experimental and control groups were significantly different for time to first manic relapse (log rank 7.04, df = 1, P = 0.008) but not for time to first depressive relapse (log rank 1.65, df = 1, P = 0.19).

[Figures 2-3 ILLUSTRATIONS OMITTED]

Table 2 shows significant reductions in the total number of manic relapses between baseline and each six month period up to 18 months in the experimental group compared with the control group but no significant differences in the length of each manic relapse if it occurred. There were no significant changes in the number or length of depressive relapses. In 18 months 3 (9%) patients in the experimental group and 2 (6%) in the control group had a relapse of mixed affective disorder.

Table 2 Intention to treat analysis of relapse and treatment in experimental and control groups

                                        No (%) with relapse or
                                        who received treatment

                                        Experimental   Control
Outcome measure (unit)                   (n=33)(*)      (n=35)

Baseline to 6 months
Mania (No of days)                         2 (6)       11 (31)
Depression (No of days)                   11 (33)       9 (26)
Baseline to 12 months
Mania (No of days)                         6 (18)      16 (46)
Depression (No of days)                   16 (48)      11 (31)
Baseline to 18 months
Mania (No of days)                         9 (27)      20 (57)
Depression (No of days)                   18 (55)      13 (37)
Admission (No of days)                    12 (36)      15 (43)
Psychiatric outpatient visits (No)        32 (97)      35 (100)
Community contacts (No)([sections])       16 (48)      18 (51)
Prescribed lithium (mg/day)               24 (73)      26 (74)
Carbamazepine (mg/day)                    13 (39)      18 (51)
Antidepressants (mg/day)([paragraph])     17 (52)      14 (40)
Neuroleptics (mg/day)(**)                 25 (76)      24 (69)

                              Median difference    P value
Outcome measure (unit)           (95% CI)         ([dagger])

Baseline to 6 months
Mania (No of days)            -25 (-43 to -8)       0.008
Depression (No of days)         8 (-14 to 29)       0.49
Baseline to 12 months
Mania (No of days)            -28 (-49 to -6)       0.016
Depression (No of days)        11 (-12 to 34)       0.35
Baseline to 18 months
Mania (No of days)            -30 (-52 to -8)       0.013
Depression (No of days)        17 (-6 to 41)        0.15
Admission (No of days)         -6 (-30 to 17)       0.16
Psychiatric outpatient
  visits (No)                  -3 (-9 to 28)        0.49
Community contacts
  (No)([sections])              3 (-21 to 27)       0.72
Prescribed lithium (mg/day)    -2 (-23 to 19)       0.88
Carbamazepine (mg/day)        -12 (-36 to 12)       0.32
Antidepressants
  (mg/day)([paragraph])        12 (-12 to 35)       0.34
Neuroleptics (mg/day)(**)       7 (-14 to 28)       0.69

                                       Median (range) length of
                                      relapse or treatment (days)

Outcome measure (unit)                Experimental     Control

Baseline to 6 months
Mania (No of days)                     15 (10-18)     39 (7-76)
Depression (No of days)                66 (8-124)     18 (10-82)
Baseline to 12 months
Mania (No of days)                     15 (10-56)     45 (7-106)
Depression (No of days)                48 (7-233)     25 (10-187)
Baseline to 18 months
Mania (No of days)                     21 (10-137)    36 (5-133)
Depression (No of days)                48 (7-238)     61 (10-187)
Admission (No of days)                 49 (2-137)     49 (5-117)
Psychiatric outpatient visits (No)      9 (4-88)       8 (2-33)
Community contacts (No)([sections])    41 (3-116)     28 (1-83)
Prescribed lithium (mg/day)           800 (93-1600)   800 (34-1336)
Carbamazepine (mg/day)                400 (12-900)    447 (4-1200)
Antidepressants
  (mg/day)([paragraph])               168 (34-332)     88 (4-303)
Neuroleptics (mg/day)(**)             113 (3-591)     153 (9-668)

                              Median difference   P value([double
Outcome measure (unit)            (95% CI)           dagger])

Baseline to 6 months
Mania (No of days)            Not computable           0.28
Depression (No of days)       21 (-5 to 77)            0.17
Baseline to 12 months
Mania (No of days)            -19 (-61 to 3)           0.14
Depression (No of days)        12 (-11 to 71)          0.081
Baseline to 18 months
Mania (No of days)            -11 (-40 to 20)          0.54
Depression (No of days)         2 (-42 to 46)          0.92
Admission (No of days)          3 (-30 to 40)          0.77
Psychiatric outpatient
  visits (No)                   1 (-1 to 3)            0.31
Community contacts
  (No)([sections])             12 (-10 to 37)          0.28
Prescribed lithium (mg/day)     0 (-200 to 191)        0.92
Carbamazepine (mg/day)         -1 (-300 to 200)        0.92
Antidepressants
  (mg/day)([paragraph])        73 (16 to 131)          0.024
Neuroleptics (mg/day)(**)     -37 (-116 to 28)         0.86