Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01145313
First received: June 15, 2010
Last updated: August 5, 2010
Last verified: August 2010
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Purpose
The primary objective is to examine changes in pre/post-augmentation healthcare costs and resource utilization in patients diagnosed with major depressive disorder (MDD) who augment their current antidepressant therapy with an atypical antipsychotic.
| Condition |
|---|
|
Depressive Disorder, Major |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic. [ Time Frame: 3 months pre- augmentation. ] [ Designated as safety issue: No ]
- Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic. [ Time Frame: 3 months post-augmentation. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- A secondary post-hoc analysis may be conducted to determine differences in outcomes among patients during a longer treatment period, ie 6 month pre- and 6 month post-augmentation. [ Time Frame: 6 month pre-augmentation ] [ Designated as safety issue: No ]
- A secondary post-hoc analysis may be conducted to determine differences in outcomes among patients during a longer treatment period, ie 6 month pre- and 6 month post-augmentation. [ Time Frame: 6 month post-augmentation ] [ Designated as safety issue: No ]
| Enrollment: | 501 |
| Study Start Date: | October 2007 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Patients diagnosed with Major Depressive Disorder
Patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy.
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The population is identified as patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy.
Criteria
Inclusion Criteria:
Patients who meet the following criteria will be included in the study:
- aged 18 to 64 years
- diagnosis of major depressive disorder during the study timeframe (ICD 9 codes 296.2, 296.3, 311)
- evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
- must be continually enrolled during the study timeframe and have both medical and pharmacy benefits
- evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
- evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic
- After at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months.
Exclusion Criteria:
Patients are excluded if they:
- have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period
- have Electroconvulsive therapy (ECT) during the study period
- new augmentation with mood stabilizers, L-thyroxine (T4), L-Thyronine (T3), buspirone, stimulant, or others during the post-period (table 1)
- are pregnant during the study period
- patients with Medicare or Medicaid
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01145313 History of Changes |
| Other Study ID Numbers: | CN138-582 |
| Study First Received: | June 15, 2010 |
| Last Updated: | August 5, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013