Patients with bipolar disorder (I or II) having a major depressive episode
Conditions
Interventions
Product Code: BF 2.649
Pharmaceutical Form: Capsule*
INN or Proposed INN: 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine, hydrochloride
Current Sponsor code: BF 2.649
Concentration unit: mg milligr
Sponsors
BIOPROJET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Administrative & socio-demographic criteria: - Written signed informed consent - Male or Female aged from 18 to 65 years old Clinical criteria: - Diagnostic : . bipolar disorder (Type I or II) according to DSM-IV criteria . major depressive episode according to DSM-IV criteria - Severity of depression: . MADRS score > 22 . CGI-BP score > or equal to 3 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: - Treatment resistant depression defined as a lack of response with 2 previous anti-depressive treatments - psychotic symptomatology - High suicidal risk in the investigator's judgement - Drugs or alcohol abuses during the previous year - Severe systemic illnesses and any illness which, according to the investigator's judgement, will expose the patient to an excessive risk - ECG: auriculo-ventricular block with PR superior to 200 ms and/or QTc superior to 450 ms - Biological tests: values considered to be abnormal by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Antidepressant efficacy (response is defined as a 50 % score reduction from baseline with MADRS);Secondary Objective: - Efficacy assessment of cognition and sleep - Safety evaluation;Primary end point(s): - MADRS score [Response to treatment is defined as a score reduction of, at least, 50 % from baseline] | — |
Countries
Belgium
Outcome results
None listed