Long-term mood/antidepressant effects of quetiapine extended-release formulation: an open-label, non-controlled extension study in Japanese patients with bipolar depression.
Adult
Affect
/ drug effects
Antidepressive Agents
/ administration & dosage
Antipsychotic Agents
/ administration & dosage
Bipolar Disorder
/ drug therapy
Delayed-Action Preparations
/ administration & dosage
Double-Blind Method
Female
Humans
Japan
/ epidemiology
Male
Middle Aged
Psychiatric Status Rating Scales
Quetiapine Fumarate
/ administration & dosage
Retrospective Studies
Treatment Outcome
Young Adult
Bipolar disorder
Depression
Quetiapine XR
Journal
BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559
Informations de publication
Date de publication:
26 06 2019
26 06 2019
Historique:
received:
31
07
2018
accepted:
13
06
2019
entrez:
28
6
2019
pubmed:
28
6
2019
medline:
31
3
2020
Statut:
epublish
Résumé
In an 8-week, randomized, placebo-controlled, double-blind study, an extended-release formulation of quetiapine, quetiapine XR, demonstrated efficacy and safety in Japanese patients with bipolar depression. Bipolar disorder is a chronic disease requiring continuous treatment. This was a long-term (52-week), open-label, non-controlled extension study to evaluate the long-term safety and efficacy of quetiapine XR in Japanese patients with bipolar depression who had previously completed the initial 8-week double-blind study. Efficacy was determined by the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Depression Scale 17-item (HAM-D The mean (SD) MADRS total score decreased from 30.9 (6.9) at baseline to 16.1 (10.6) at week 8, and eventually to 9.1 (8.7) at week 52. The sustained efficacy of quetiapine XR treatment was also shown using HAM-D The efficacy of quetiapine XR was sustained long-term and no new safety concerns were identified in Japanese patients with bipolar depression. ClinicalTrials.gov Registration: NCT01725308. Date of registration; 12th November 2012 (retrospectively registered).
Sections du résumé
BACKGROUND
In an 8-week, randomized, placebo-controlled, double-blind study, an extended-release formulation of quetiapine, quetiapine XR, demonstrated efficacy and safety in Japanese patients with bipolar depression. Bipolar disorder is a chronic disease requiring continuous treatment.
METHODS
This was a long-term (52-week), open-label, non-controlled extension study to evaluate the long-term safety and efficacy of quetiapine XR in Japanese patients with bipolar depression who had previously completed the initial 8-week double-blind study. Efficacy was determined by the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Depression Scale 17-item (HAM-D
RESULTS
The mean (SD) MADRS total score decreased from 30.9 (6.9) at baseline to 16.1 (10.6) at week 8, and eventually to 9.1 (8.7) at week 52. The sustained efficacy of quetiapine XR treatment was also shown using HAM-D
CONCLUSIONS
The efficacy of quetiapine XR was sustained long-term and no new safety concerns were identified in Japanese patients with bipolar depression.
TRIAL REGISTRATION
ClinicalTrials.gov Registration: NCT01725308. Date of registration; 12th November 2012 (retrospectively registered).
Identifiants
pubmed: 31242884
doi: 10.1186/s12888-019-2181-9
pii: 10.1186/s12888-019-2181-9
pmc: PMC6595609
doi:
Substances chimiques
Antidepressive Agents
0
Antipsychotic Agents
0
Delayed-Action Preparations
0
Quetiapine Fumarate
2S3PL1B6UJ
Banques de données
ClinicalTrials.gov
['NCT01725308']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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