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

Purpose

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	Intervention	Phase
Major Depressive Disorder (MDD)	Drug: Escitalopram Drug: Aripiprazole Drug: Aripiprazole/Escitalopram combination	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Citalopram hydrobromide Citalopram Aripiprazole Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:

Mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: from Week 8 to Week 14 ] [ Designated as safety issue: No ]
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.

Enrollment:	66
Study Start Date:	July 2010
Study Completion Date:	December 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111552

Show 60 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

More Information

No publications provided

Responsible Party:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT01111552 History of Changes
Other Study ID Numbers:	31-08-256
Study First Received:	April 22, 2010
Last Updated:	August 24, 2012
Health Authority:	United States: Food and Drug Administration

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

Major Depressive Disorder
MDD
Depression

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Aripiprazole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antipsychotic Agents

ClinicalTrials.gov processed this record on May 16, 2013

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