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

NCT01145313 | Completed

• 1 other identifier: CN138-582
• Study Type: observational
• Target: 501
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Patients diagnosed with Major Depressive Disorder

Patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 16, 2010
• Study Start: October 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 8, 2013

Record last verified: 2010-08