Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder

This study has been completed.

Sponsored by:	Validus Pharmaceuticals
Information provided by:	Validus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00150605

Purpose

The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Extended-release carbamazepine	Phase III

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Carbamazepine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder

Further study details as provided by Validus Pharmaceuticals:

Primary Outcome Measures:

Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment

Secondary Outcome Measures:

YMRS Scale
Clinical Global Impressions Scale - Bipolar Version
HAM-D and MADRS Scales for Depression

Estimated Enrollment:	50
Study Start Date:	February 2005
Estimated Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV criteria for Bipolar I disorder
Screening YMRS score =>16
Women of childbearing potential agree to take adequate precautions against contraception
Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic

Exclusion Criteria:

Hospitalization required for treatment of psychiatric symptoms
Patients who meet DSM-IV for ultra-rapid cycling
History of serious suicide attempt requiring medical intervention
Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	SPD417-308
Study First Received:	September 6, 2005
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00150605
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Affective Disorders, Psychotic
Carbamazepine
Mental Disorders

Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antimanic Agents
Pharmacologic Actions
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009