Major Depressive Disorder
Conditions
Brief summary
To examine the safety and efficacy of long term administration of aripiprazole as an adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor (SSRI) or a selective-norepinephrine reuptake inhibitor (SNRI), in subjects with major depressive disorder.
Interventions
DRUGOPC-14597 (Aripiprazole)
administered orally once daily, 3 to 15 mg daily, 52 weeks
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
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 antidepressant 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline(Day 1), Week52 or at discontinuation | Change from baseline to Last Observation Carried Forward (LOCF). Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1\. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuing Subjects Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study | 122 |
| Newly Entering Subjects Newly entering elderly patients with major depressive disorder, aged 65 and above | 33 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 10 |
| Overall Study | change of residence or other commitments | 5 | 0 |
| Overall Study | Diabetic glucose level or HbA1C>=6.5% | 2 | 0 |
| Overall Study | Lack of Efficacy | 3 | 0 |
| Overall Study | Physician Decision | 5 | 1 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 7 | 2 |
| Overall Study | Withdrawal by Subject | 13 | 10 |
Baseline characteristics
| Characteristic | Continuing Subjects | Newly Entering Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 33 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 122 Participants | 0 Participants | 122 Participants |
| Age, Continuous | 39.1 years STANDARD_DEVIATION 8.6 | 73.1 years STANDARD_DEVIATION 5.6 | 46.3 years STANDARD_DEVIATION 16.1 |
| Region of Enrollment Japan | 122 participants | 33 participants | 155 participants |
| Sex: Female, Male Female | 55 Participants | 23 Participants | 78 Participants |
| Sex: Female, Male Male | 67 Participants | 10 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 111 / 122 | 29 / 33 |
| serious Total, serious adverse events | 2 / 122 | 4 / 33 |
Outcome results
Primary
Montgomery-Asberg Depression Rating Scale (MADRS)
Change from baseline to Last Observation Carried Forward (LOCF). Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1\. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts
Time frame: Baseline(Day 1), Week52 or at discontinuation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuing Subjects | Montgomery-Asberg Depression Rating Scale (MADRS) | -4.60 Rating Score | Standard Error 0.8 |
| Newly Entering Subjects | Montgomery-Asberg Depression Rating Scale (MADRS) | -10.5 Rating Score | Standard Error 1.9 |