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Trial record 67 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

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. Identifier: NCT00150605
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 2, 2007
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

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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

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Layout table for additonal information Identifier: NCT00150605    
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:
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Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Psychotropic Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action