ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00150605
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 2, 2007
Sponsor:
Information provided by:
Validus Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Extended-release carbamazepine Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment

Secondary Outcome Measures :
  1. YMRS Scale
  2. Clinical Global Impressions Scale - Bipolar Version
  3. HAM-D and MADRS Scales for Depression


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

ClinicalTrials.gov Identifier: NCT00150605     History of Changes
Other Study ID Numbers: SPD417-308
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: June 2006

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Carbamazepine
Psychotropic Drugs
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action