Bipolar Depression at Phase II study with patients. Lu AA34893 is a novel compound under development by H. Lundbeck A/S as an antidepressant. MedDRA version: 9.1 Level: LLT Classification code 10004936 Term: Bipolar depression
Conditions
Interventions
Product Name: Lu AA34893
Product Code: Lu AA34893
Pharmaceutical Form: Capsule, hard
Current Sponsor code: Lu AA34893
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
H. Lundbeck a/s
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·The patient fulfils the DSM-IV-TR criteria of a current major depressive episode of Bipolar Disorder I or Bipolar Disorder II, lasting for at least 30 days before screening ·The patient has a documented history of at least one manic and/or hypomanic episode within the past 15 years. ·The patient has a MADRS total score of 26 or higher and a YMRS total score of 8 or less at screening and baseline visits. ·The patient is a man or woman, aged between 18 and 65 years (extremes included), ·The patient is an in-patient in a psychiatric hospital or an out-patient at a psychiatric setting. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Any current psychiatric or neurological disorder other than Bipolar Disorder as defined in the DSM-IV-TR ·Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. ·The patient has a history of very rapid cycling ·The patient has, in the Investigator’s opinion, a significant risk of suicide ·The patient has received quetiapine as treatment for the current depressive episode ·The patient’s current depressive episode has been non-responsive to two or more adequate antidepressant treatments of at least 6 weeks duration ·The patient’s current depressive episode has been non-responsive to two or more antipsychotic treatments of at least 6 weeks duration ·The patient is currently treated or has been treated within 2 weeks prior to randomisation with one or more mood stabilisers, lamotrigine, anti-psychotic or antidepressive drugs. The patient requires ECT or has received ECT within the last 6 months. ·The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Lu AA34893 versus placebo in the treatment of depression by means of the Change from Baseline in the MADRS total score at Week 8 in patients with Bipolar I or II Disorder. ;Secondary Objective: Evaluate: -safety + tolerability of 3 dose regimens of Lu AA34893 vs plb during 12-w treatment. -effect of treatment with Lu AA34893 on patient-reported outcomes and resource utilisation. -occurrence of (hypo)mania, by frequency of diagnosis and change from baseline of YMRS total score, during 12-w treatment with 3 dose regimes of Lu AA34893. Assess: -efficacy of 3 dose regimens of Lu AA34893 vs plb in treatment of depression by means of Change from baseline in MADRS + HAM-D total scores and CGI-BP part I + II scores by visit. -number of responders and remitters during treatment with 3 dose regimens of Lu AA34893 vs plb. -efficacy of 3 dose regimens of Lu AA34893 on anxiety symptoms by means of the change from baseline in total HAM-A score. -potential for inducing EPS AEs by change from baseline in SAS, AIMS and BARS total score. -efficacy and safety of quetiapine vs plb on same parameters mentioned for Lu AA34893. -population PK parameters of Lu AA34893;Primary end point(s): the change from baseline in total MADRS score at week 8 (by LOCF) | — |
Countries
Austria, Belgium, France, Germany, Lithuania, Sweden, United Kingdom
Outcome results
None listed