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

This study has been completed.
Sponsor:
Information provided by:
Validus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00150605
First received: September 6, 2005
Last updated: November 1, 2007
Last verified: June 2006
History of Changes
  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 3

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
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 May 23, 2013