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

This study has been completed.

First Received on September 6, 2005. Last Updated on November 1, 2007 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Carbamazepine

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Carbamazepine
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012