Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder

Depressive Disorder, Major Clinical Trial

Official title:

Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145313
• Other study ID #: CN138-582
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: November 7, 2013
• Start date: October 2007
• Est. completion date: June 2010

Study information

• Verified date: August 2010
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic.		3 months pre- augmentation.	No
Primary	Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic.		3 months post-augmentation.	No
Secondary	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.		6 month pre-augmentation	No
Secondary	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.		6 month post-augmentation	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form