TAK375 as treatment for depression associated with Bipolar 1 Disorder
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) 0.1 mg and 0.4 mg as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated With Bipolar 1 Disorder in Adult Subjects
IRAS ID
112598
Contact name
John Geddes
Sponsor organisation
Takeda Global Research & Development Centre (Europe) Ltd (TGRD)
Eudract number
2012-001357-10
Clinicaltrials.gov Identifier
Research summary
Bipolar disorder is a severe and chronic illness, affecting approximately 1% of the population. Whilst successful treatment of the disorder is possible the illness can have a devastating impact on patients who are not successfully treated. This Phase 3, randomised, double-blind, placebo-controlled study has been designed to assess the effect of two dose levels of the study drug (TAK-375SL) compared with placebo. Between 276 and 870 patients will be randomized (in a 1:1:1 ratio) into three treatment groups (TAK-375SL 0.1 mg, TAK-375SL 0.4 mg or placebo control). This trial will include male and female patients aged between 18 and 75 years, with acute depressive episodes associated with Bipolar 1 Disorder. Patients must meet the diagnostic criteria from the DSM-IV-TR for Bipolar 1 Disorder in order to participate. Patients may be on lithium and/or one mood stabilizer and/or one atypical antipsychotic. No change in the dose of the allowed medications is permitted for two weeks prior to screening (and at least 6 weeks prior to screening for lamotrigine only) and for the duration of the study except for downward dose adjustments for adverse events. Patients will be seen twice during the first week of treatment, at Week 2 of treatment and then every 2 weeks up to the end of the 6-week treatment period. Patients who complete the 6-week treatment period will have a follow-up visit approximately 7-10 days after the last visit. A safety follow-up phone call will be made 30 days after completion of the 6-week treatment period. This study plans to conduct one unblinded interim analysis after the first 276 patients have been enrolled and treated. Based on the interim analysis, the study plans to adapt aspects of the study design. The primary objective of this study is to evaluate the effect of TAK-375SL 0.1 mg and 0.4 mg once daily at bedtime compared with placebo as assessed by the Montgomery-Ç?sberg Depression Rating Scale after 6 weeks of treatment in patients with acute depressive episodes associated with Bipolar 1 Disorder.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
12/EM/0391
Date of REC Opinion
29 Oct 2012
REC opinion
Favourable Opinion