Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study
Abstract Background The current study evaluated the long-term (52 week) safety and impact on symptom measures of lurasidone (with or without lithium or valproate) for the treatment of bipolar I disorder in Japanese patients. Methods Bipolar patients for this open-label flexibly dosed lurasidone (20–...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2021-08-01
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| Series: | International Journal of Bipolar Disorders |
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| Online Access: | https://doi.org/10.1186/s40345-021-00230-8 |
| _version_ | 1818920890111361024 |
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| author | Teruhiko Higuchi Tadafumi Kato Mari Miyajima Kei Watabe Takahiro Masuda Katsuhiko Hagi Jun Ishigooka |
| author_facet | Teruhiko Higuchi Tadafumi Kato Mari Miyajima Kei Watabe Takahiro Masuda Katsuhiko Hagi Jun Ishigooka |
| author_sort | Teruhiko Higuchi |
| collection | DOAJ |
| description | Abstract Background The current study evaluated the long-term (52 week) safety and impact on symptom measures of lurasidone (with or without lithium or valproate) for the treatment of bipolar I disorder in Japanese patients. Methods Bipolar patients for this open-label flexibly dosed lurasidone (20–120 mg/day) study were recruited from those with a recent/current depressive episode who completed an initial 6 week, double-blind, placebo-controlled, lurasidone study (depressed group), and those with a recent/current manic, hypomanic, or mixed episode (non-depressed group) who agreed to enroll directly into the long-term study. Measures of adverse events and safety included treatment-emergent adverse events, vital signs, body weight, ECG, laboratory tests, and measures of suicidality and extrapyramidal symptoms. Symptom measures included Montgomery Åsberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS). Results The most common adverse events associated with lurasidone were akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%). Minimal changes in lipids and measures of glycemic control occurred. Mean change in body weight was + 1.0 kg in the non-depressed group and − 0.8 kg in the depressed group. MADRS total scores declined by a mean (SD) of 2.0 (14.7) points from long-term baseline to endpoint in the depressed group who had received placebo in the prior 6 week trial. The depressed group that had received lurasidone during the prior 6 week study maintained their depressive symptom improvements. For the non-depressed group, YMRS total scores decreased over time. Limitations No control group was included, treatment was open-label, and 49.7% of patients completed the 52 week study. Conclusions Long-term treatment with lurasidone 20–120 mg/day for Japanese patients with bipolar disorder maintained improvements in depressive symptoms for depressed patients who were treated in a prior 6 week trial and led to improvements in manic symptoms among a newly recruited subgroup of patients with a recent/current manic, hypomanic, or mixed episode. Few changes in weight or metabolic parameters were evident. Clinical trial registration: JapicCTI-132319, clinicaltrials.gov—NCT01986114. |
| first_indexed | 2024-12-20T01:28:56Z |
| format | Article |
| id | doaj.art-005584de0d2840eaa918355be3248da7 |
| institution | Directory Open Access Journal |
| issn | 2194-7511 |
| language | English |
| last_indexed | 2024-12-20T01:28:56Z |
| publishDate | 2021-08-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | International Journal of Bipolar Disorders |
| spelling | doaj.art-005584de0d2840eaa918355be3248da72022-12-21T19:58:10ZengSpringerOpenInternational Journal of Bipolar Disorders2194-75112021-08-019111210.1186/s40345-021-00230-8Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label studyTeruhiko Higuchi0Tadafumi Kato1Mari Miyajima2Kei Watabe3Takahiro Masuda4Katsuhiko Hagi5Jun Ishigooka6Japan Depression CenterLaboratory for Molecular Dynamics of Mental Disorders, RIKEN Center for Brain ScienceSumitomo Dainippon Pharma Co., LtdSumitomo Dainippon Pharma Co., LtdSumitomo Dainippon Pharma Co., LtdSumitomo Dainippon Pharma Co., LtdInstitute of CNS PharmacologyAbstract Background The current study evaluated the long-term (52 week) safety and impact on symptom measures of lurasidone (with or without lithium or valproate) for the treatment of bipolar I disorder in Japanese patients. Methods Bipolar patients for this open-label flexibly dosed lurasidone (20–120 mg/day) study were recruited from those with a recent/current depressive episode who completed an initial 6 week, double-blind, placebo-controlled, lurasidone study (depressed group), and those with a recent/current manic, hypomanic, or mixed episode (non-depressed group) who agreed to enroll directly into the long-term study. Measures of adverse events and safety included treatment-emergent adverse events, vital signs, body weight, ECG, laboratory tests, and measures of suicidality and extrapyramidal symptoms. Symptom measures included Montgomery Åsberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS). Results The most common adverse events associated with lurasidone were akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%). Minimal changes in lipids and measures of glycemic control occurred. Mean change in body weight was + 1.0 kg in the non-depressed group and − 0.8 kg in the depressed group. MADRS total scores declined by a mean (SD) of 2.0 (14.7) points from long-term baseline to endpoint in the depressed group who had received placebo in the prior 6 week trial. The depressed group that had received lurasidone during the prior 6 week study maintained their depressive symptom improvements. For the non-depressed group, YMRS total scores decreased over time. Limitations No control group was included, treatment was open-label, and 49.7% of patients completed the 52 week study. Conclusions Long-term treatment with lurasidone 20–120 mg/day for Japanese patients with bipolar disorder maintained improvements in depressive symptoms for depressed patients who were treated in a prior 6 week trial and led to improvements in manic symptoms among a newly recruited subgroup of patients with a recent/current manic, hypomanic, or mixed episode. Few changes in weight or metabolic parameters were evident. Clinical trial registration: JapicCTI-132319, clinicaltrials.gov—NCT01986114.https://doi.org/10.1186/s40345-021-00230-8LurasidoneBipolar disorderAtypical antipsychotic |
| spellingShingle | Teruhiko Higuchi Tadafumi Kato Mari Miyajima Kei Watabe Takahiro Masuda Katsuhiko Hagi Jun Ishigooka Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study International Journal of Bipolar Disorders Lurasidone Bipolar disorder Atypical antipsychotic |
| title | Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study |
| title_full | Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study |
| title_fullStr | Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study |
| title_full_unstemmed | Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study |
| title_short | Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study |
| title_sort | lurasidone in the long term treatment of japanese patients with bipolar i disorder a 52 week open label study |
| topic | Lurasidone Bipolar disorder Atypical antipsychotic |
| url | https://doi.org/10.1186/s40345-021-00230-8 |
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