Abstract
Background: Ziprasidone, adjunctive to either lithium or valproate, has previously been shown to be associated with a significantly lower risk of relapse in bipolar disorder compared with lithium or valproate treatment alone. Methods: This placebo-controlled outpatient trial with ziprasidone adjunctive to lithium or valproate or lithium and valproate alone, for subjects with a recent or current manic or mixed episode of bipolar I disorder, comprised a 2.5- to 4-month, open-label stabilization period, followed by a 6-month, double-blind maintenance period. These post hoc analyses characterize the relapse outcomes by dose, relapse types and timing as well as all-reason discontinuations during the maintenance period. Results: Time to relapse and all-reason discontinuation were both statistically significant in favor of the ziprasidone 120 mg/day group compared with placebo (p=0.004 and 0.001, respectively) during the 6-month double-blind period. There was no difference in time to relapse in the 80 and 160 mg/day dose groups compared with placebo (p=0.16 and 0.40, respectively) and, likewise, for time to all-reason discontinuation (p=0.20 for both doses). The majority of relapses in each group occurred prior to week 8, and most were depressive in nature. Limitations: The primary study was not designed to compare relapse rates by dose groups. Conclusions: These analyses confirm the effectiveness of ziprasidone (80-160 mg/day) in preventing relapses in subjects with bipolar disorder, with the 120 mg/day dosage appearing to have the highest relapse prevention rate.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 171-175 |
| Number of pages | 5 |
| Journal | Journal of Affective Disorders |
| Volume | 144 |
| Issue number | 1-2 |
| DOIs | |
| State | Published - Jan 10 2013 |
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Keywords
- Bipolar disease
- Relapse prevention
- Ziprasidone
ASJC Scopus subject areas
- Psychiatry and Mental health
- Clinical Psychology
Cite this
Characterizing relapse prevention in bipolar disorder with adjunctive ziprasidone : Clinical and methodological implications. / Bowden, Charles L.; Karayal, Onur N.; Schwartz, Jeffrey H.; Gundapaneni, Balarama K.; O'Gorman, Cedric.
In: Journal of Affective Disorders, Vol. 144, No. 1-2, 10.01.2013, p. 171-175.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Characterizing relapse prevention in bipolar disorder with adjunctive ziprasidone
T2 - Clinical and methodological implications
AU - Bowden, Charles L.
AU - Karayal, Onur N.
AU - Schwartz, Jeffrey H.
AU - Gundapaneni, Balarama K.
AU - O'Gorman, Cedric
PY - 2013/1/10
Y1 - 2013/1/10
N2 - Background: Ziprasidone, adjunctive to either lithium or valproate, has previously been shown to be associated with a significantly lower risk of relapse in bipolar disorder compared with lithium or valproate treatment alone. Methods: This placebo-controlled outpatient trial with ziprasidone adjunctive to lithium or valproate or lithium and valproate alone, for subjects with a recent or current manic or mixed episode of bipolar I disorder, comprised a 2.5- to 4-month, open-label stabilization period, followed by a 6-month, double-blind maintenance period. These post hoc analyses characterize the relapse outcomes by dose, relapse types and timing as well as all-reason discontinuations during the maintenance period. Results: Time to relapse and all-reason discontinuation were both statistically significant in favor of the ziprasidone 120 mg/day group compared with placebo (p=0.004 and 0.001, respectively) during the 6-month double-blind period. There was no difference in time to relapse in the 80 and 160 mg/day dose groups compared with placebo (p=0.16 and 0.40, respectively) and, likewise, for time to all-reason discontinuation (p=0.20 for both doses). The majority of relapses in each group occurred prior to week 8, and most were depressive in nature. Limitations: The primary study was not designed to compare relapse rates by dose groups. Conclusions: These analyses confirm the effectiveness of ziprasidone (80-160 mg/day) in preventing relapses in subjects with bipolar disorder, with the 120 mg/day dosage appearing to have the highest relapse prevention rate.
AB - Background: Ziprasidone, adjunctive to either lithium or valproate, has previously been shown to be associated with a significantly lower risk of relapse in bipolar disorder compared with lithium or valproate treatment alone. Methods: This placebo-controlled outpatient trial with ziprasidone adjunctive to lithium or valproate or lithium and valproate alone, for subjects with a recent or current manic or mixed episode of bipolar I disorder, comprised a 2.5- to 4-month, open-label stabilization period, followed by a 6-month, double-blind maintenance period. These post hoc analyses characterize the relapse outcomes by dose, relapse types and timing as well as all-reason discontinuations during the maintenance period. Results: Time to relapse and all-reason discontinuation were both statistically significant in favor of the ziprasidone 120 mg/day group compared with placebo (p=0.004 and 0.001, respectively) during the 6-month double-blind period. There was no difference in time to relapse in the 80 and 160 mg/day dose groups compared with placebo (p=0.16 and 0.40, respectively) and, likewise, for time to all-reason discontinuation (p=0.20 for both doses). The majority of relapses in each group occurred prior to week 8, and most were depressive in nature. Limitations: The primary study was not designed to compare relapse rates by dose groups. Conclusions: These analyses confirm the effectiveness of ziprasidone (80-160 mg/day) in preventing relapses in subjects with bipolar disorder, with the 120 mg/day dosage appearing to have the highest relapse prevention rate.
KW - Bipolar disease
KW - Relapse prevention
KW - Ziprasidone
UR - http://www.scopus.com/inward/record.url?scp=84870293932&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84870293932&partnerID=8YFLogxK
U2 - 10.1016/j.jad.2012.04.024
DO - 10.1016/j.jad.2012.04.024
M3 - Article
VL - 144
SP - 171
EP - 175
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
SN - 0165-0327
IS - 1-2
ER -