Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With 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:	NCT00150553

Purpose

The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms

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:

Score on Young Mania Rating Scale (YMRS) at 12 weeks

Secondary Outcome Measures:

Time to remission
Clinical Global Impressions Scale - Bipolar Version
HAM-D and MADRS scales for depression

Estimated Enrollment:	102
Study Start Date:	January 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
Screen YMRS score => 16
Women of childbearing potential agree to take adequate precautions against contraception

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00150553 History of Changes
Other Study ID Numbers:	SPD417-306
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
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
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012