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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Drug: Escitalopram Drug: Aripiprazole Drug: Aripiprazole/Escitalopram combination Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2010
Primary Completion Date : July 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Escitalopram monotherapy Drug: Escitalopram
Escitalopram monotherapy
Active Comparator: Aripiprazole monotherapy Drug: Aripiprazole
Aripiprazole monotherapy
Active Comparator: Aripiprazole/Escitalopram combination therapy Drug: Aripiprazole/Escitalopram combination
Aripiprazole/Escitalopram combination therapy

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111552

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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
More Information

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01111552     History of Changes
Other Study ID Numbers: 31-08-256
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists