TY - JOUR
T1 - Open-label aripiprazole in the treatment of acute bipolar depression
T2 - A prospective pilot trial
AU - McElroy, Susan L.
AU - Suppes, Trisha
AU - Frye, Mark A.
AU - Altshuler, Lori L.
AU - Stanford, Kevin
AU - Martens, Brian
AU - Leverich, Gabriele S.
AU - Post, Robert M.
AU - Keck, Paul E.
N1 - Funding Information:
This study was supported by a grant from the Stanley Medical Research Institute and has been registered at Clinical Trials.gov. Its ID number is NCT00363337. Study medication (aripiprazole) was provided by Bristol-Myers Squibb. The following investigators have the following potential conflict of interests.
PY - 2007/8
Y1 - 2007/8
N2 - Background: Increasing evidence indicates that some second-generation antipsychotics are efficacious in bipolar depression, but there are few data on this illness for the novel agent aripiprazole. Methods: Aripiprazole response was prospectively assessed for 8 weeks with the Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP), and the Young Mania Rating Scale (YMRS) in 31 bipolar patients with acute depression inadequately responsive to 1 mood stabilizer. Side effects and body weight were also evaluated. Outcome measures were analyzed with repeated measures ANOVAs. Results: Patients showed a significant decrease in mean MADRS total and CGI-BP-Depression Severity scores, but only 14 (45%) completed the 8-week trial. Thirteen (42%) patients met criteria for response (≥ 50% reduction in MADRS total score), 11 (35%) patients met criteria for remission (final MADRS total score ≤ 12), and 9 (29%) patients discontinued aripiprazole for side effects, most commonly akathisia (N = 4). As a group, patients showed statistically insignificant weight gain (0.8 ± 2.5 kg) over the 8-week trial. Conclusion: Aripiprazole was associated with beneficial effects on mood in some patients with bipolar depression, but also had a high discontinuation rate, primarily due to side effects. Double-blind, placebo-controlled studies are necessary to determine aripiprazole's efficacy, tolerability, and safety in bipolar depression.
AB - Background: Increasing evidence indicates that some second-generation antipsychotics are efficacious in bipolar depression, but there are few data on this illness for the novel agent aripiprazole. Methods: Aripiprazole response was prospectively assessed for 8 weeks with the Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP), and the Young Mania Rating Scale (YMRS) in 31 bipolar patients with acute depression inadequately responsive to 1 mood stabilizer. Side effects and body weight were also evaluated. Outcome measures were analyzed with repeated measures ANOVAs. Results: Patients showed a significant decrease in mean MADRS total and CGI-BP-Depression Severity scores, but only 14 (45%) completed the 8-week trial. Thirteen (42%) patients met criteria for response (≥ 50% reduction in MADRS total score), 11 (35%) patients met criteria for remission (final MADRS total score ≤ 12), and 9 (29%) patients discontinued aripiprazole for side effects, most commonly akathisia (N = 4). As a group, patients showed statistically insignificant weight gain (0.8 ± 2.5 kg) over the 8-week trial. Conclusion: Aripiprazole was associated with beneficial effects on mood in some patients with bipolar depression, but also had a high discontinuation rate, primarily due to side effects. Double-blind, placebo-controlled studies are necessary to determine aripiprazole's efficacy, tolerability, and safety in bipolar depression.
KW - Akathisia
KW - Aripiprazole
KW - Bipolar
KW - Depression
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U2 - 10.1016/j.jad.2006.11.025
DO - 10.1016/j.jad.2006.11.025
M3 - Article
C2 - 17229469
AN - SCOPUS:34247163368
SN - 0165-0327
VL - 101
SP - 275
EP - 281
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
IS - 1-3
ER -