Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Aripiprazole (Fixed dose); Aripiprazole (Titrated dose); Placebo
Intervention description: administered orally once daily, 3 mg daily, 6 weeks; administered orally once daily, 3 to 15 mg daily, 6 weeks; administered orally once daily, 6 weeks
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 586.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy
      co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a
      serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive
      disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who are either inpatients or outpatients

          2. Patients who have the ability to understand and to provide informed consent to the
             examination, observation, and evaluation processes specified in this protocol, and
             have signed the informed consent form based on a full understanding of the trial

          3. Patients diagnosed as having either "296.2x Major Depressive Disorder, Single Episode"
             or "296.3x Major Depressive Disorder, Recurrent" according to DSM-IV-TR, and for whom
             the current episode of major depressive disorder has been ongoing for more than 8
             weeks

          4. Patients with a HAM-D17 total score of 18 or more

        Exclusion Criteria:

          1. Female patients of child bearing potential who wish to become pregnant during the
             treatment period, or within 4 weeks after study completion/discontinuation

          2. Female patients who are pregnant, possibly pregnant, or breast feeding

          3. Patients judged to be unable to tolerate any type of antidpressant treatment
             (including drugs not being used in the current episode of major depressive disorder),
             based on treatment history to date

          4. Patients who have previously received electro-convulsive therapy

          5. Patients who have participated in clinical studies on medical devices or other drugs
             within the past month

          6. Patients at risk of having serious adverse events or developing symptoms that could
             interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia
             syndrome overlapping with symptoms of depression), based on previous medical history

          7. Patients with a history or a complication of diabetes

          8. Patients with thyroid disease (excluding patients who are stabilized on drug therapy
             for at least 3 months)

          9. Patients with a history of serotonin syndrome or psychotropic neuroleptic malignant
             syndrome

         10. Patients with a history of seizure disorder (epilepsy etc.)