Clinical study to evaluate the efficacy and safety of SPD489 in combination with an antidepressant in adult patients in which the monoadministation of the antidepressant alone was not efficacious
- Conditions
- Major Depressive DisorderMedDRA version: 15.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-003006-25-IT
- Lead Sponsor
- SHIRE PHARMACEUTICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1034
- Subject has a primary diagnosis of non-psychotic MDD (single or recurrent) as defined by Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition – Text Revision? (SCID-CT) that has lasted ?8 weeks prior to the Screening Visit (Visit 1). - Subject has a MADRS total score ?24 at the Lead-in Baseline Visit (Visit 2)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1012
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
- Subject whose current episode of MDD has not responded to an adequate treatment regimen (at least 6 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more approved single antidepressant agents. Any subject whose current episode of MDD has not responded to an approved adjunctive treatment strategy is to be excluded. - Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment (at least 8 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more treatment regimens, including, distinct classes of approved single antidepressant agents and adjunctive treatment strategies. - Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator. - Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Excluded are: any significant Axis II disorder (including borderline personality disorder), any bipolar disorder, any current or lifetime psychosis, post traumatic stress disorder, obsessive compulsive disorder, any pervasive development disorder, anorexia nervosa and bulimia nervosa. - a history of serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a simulant medication, a history of moderate to severe hypertension or an average (of 3 readings) resting sitting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at the Screening Visit (Visit 1) and/or the Lead-in Baseline Visit (Visit 2), or current chronic or acute illness or unstable medical conditions that may deteriorate that could confound the results of safety assessments, increase risk to subjetc, or lead to difficulty complying with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to demonstrate the efficacy of SPD489 when used as augmentation therapy in the treatment of major depressive disorder (MDD) in inadequate responders following an 8 week course of treatment with an antidepressant, as measured by the mean change in Montgomery ?sberg Depression Rating Scale (MADRS) total scores.;Secondary Objective: The key secondary objective is to demonstrate the effect of SPD489, when used as augmentation therapy in the treatment of MDD in inadequate responders following an 8-week course of treatment with an antidepressant, on quality of life (QoL) as measured by the Sheehan Disability Scale (SDS).<br>Additional secondary opbjectives are described in the protocol.;Primary end point(s): Change from the Augmentation Baseline Visit (Visit 8) to Visit 14 in MADRS total score.;Timepoint(s) of evaluation of this end point: Change from the Augmentation Baseline Visit (Visit 8) to Visit 14 in MADRS total score.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from the Augmentation Baseline Visit (Visit 8) to Visit 14 in SDS total score. Addictional secondary endoints are described in the Protocol.;Timepoint(s) of evaluation of this end point: Change from the Augmentation Baseline Visit (Visit 8) to Visit 14 in SDS total score. Addictional secondary endoints are described in the Protocol.