An 8 Week Study to Evaluate Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder - Full Text View

Purpose

The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.

Condition	Intervention	Phase
Bipolar I Depression	Drug: Armodafinil	Phase II

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Armodafinil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	An 8 Week Double Blind, Placebo-Controlled, Parallel Group, Fixed Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Further study details as provided by Cephalon:

Primary Outcome Measures:

Determine if armodafinil treatment is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder, as assessed by the IDS-C30. [ Time Frame: 8 weeks, and at Intermediate Points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MADRS, QIDS-SR16, Q-LES-Q-SF, HAM-A, CGI-BP [ Time Frame: 8 weeks, and at Intermediate Points ] [ Designated as safety issue: No ]
YMRS [ Time Frame: 8 weeks, and at Intermediate Points ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Armodafinil Patients will begin oral treatment with armodafinil or placebo, which will be titrated to 150 mg/day (3 tablets) of the randomly assigned study drug (armodafinil or placebo).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

The patient has a diagnosis of Bipolar I Disorder and is currently experiencing a major depressive episode.
The patient is currently being treated with 1 or 2 of the following drugs: lamotrigine, lithium, olanzapine, or valproic acid.

Key Exclusion Criteria:

The patient has any Axis I disorder apart from Bipolar I Disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine and caffeine dependence).
The patient has any clinically significant uncontrolled medical or surgical condition.
The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481195

Contacts


Contact: Cephalon, Inc. Contact	1-877-CEPHTRY

Show 55 Study Locations

Sponsors and Collaborators

Cephalon

More Information

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	C10953/2032/DP/US
First Received:	May 30, 2007
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00481195
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Modafinil

Behavioral Symptoms

Additional relevant MeSH terms:

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Stimulants

Protective Agents

Neuroprotective Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00481195