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Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder (MDD) (ACES 256)

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ClinicalTrials.gov Identifier: NCT01111552
Recruitment Status : Terminated
First Posted : April 27, 2010
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE April 22, 2010
First Posted Date  ICMJE April 27, 2010
Last Update Posted Date August 31, 2012
Study Start Date  ICMJE July 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2011)
Mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: from Week 8 to Week 14 ]
The primary efficacy endpoint is the mean change from the end of Week 8 Visit to the end of Week 14 Visit in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2010)
Mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from the end of Phase B to the end of Phase C [ Time Frame: End of Phase B (week 8 visit) to end of Phase C (week 14 visit) ]
The primary efficacy endpoint is the mean change from the end of Phase B (Week 8 Visit) to the end of Phase C (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score using the Last-Observation-Carried-Forward (LOCF) data set. Additionally, a Mixed-Effect Repeated Measures (MMRM) model will be used as a sensitivity analysis for the change from the end of Phase B (Week 8 Visit) to the end of Phase C (Week 14 Visit) on the MADRS Total Score.
Change History Complete list of historical versions of study NCT01111552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder (MDD)
Official Title  ICMJE A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder
Brief Summary This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in subjects with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the subject's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the subject's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.
Detailed Description

The study will be organized as follows:

  • Screening Phase
  • Single-blind Prospective Treatment Phase
  • Single-blind Continuation Phase (Responder) or Double-blind Randomization Phase (non-Responder)
  • 30 day Post Treatment Follow-up

Assigned Interventions:

  • Escitalopram monotherapy
  • Aripiprazole/Escitalopram combination therapy
  • Aripiprazole monotherapy
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder (MDD)
Intervention  ICMJE
  • Drug: Escitalopram
    Escitalopram monotherapy
  • Drug: Aripiprazole
    Aripiprazole monotherapy
  • Drug: Aripiprazole/Escitalopram combination
    Aripiprazole/Escitalopram combination therapy
Study Arms  ICMJE
  • Active Comparator: Escitalopram monotherapy
    Intervention: Drug: Escitalopram
  • Active Comparator: Aripiprazole monotherapy
    Intervention: Drug: Aripiprazole
  • Active Comparator: Aripiprazole/Escitalopram combination therapy
    Intervention: Drug: Aripiprazole/Escitalopram combination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 13, 2012)
66
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2010)
1200
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with a current diagnosis of a major depressive episode. The current depressive episode must be ≥ 8 weeks in duration
  • Subjects willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period
  • Subjects with a HAM-D17 Total Score ≥ 18 at the Baseline Visit for the Prospective Treatment Phase

Exclusion Criteria:

  • Lack of prior treatment with an antidepressant during the current depressive episode
  • Subjects who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode.
  • Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode
  • Subjects with epilepsy or significant history of seizure disorders
  • Subjects with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
  • Subjects who have received electroconvulsive therapy (ECT) in the last 10 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   India,   Philippines,   Romania,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01111552
Other Study ID Numbers  ICMJE 31-08-256
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP