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

A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150605

Enrollment

Registered

2005-09-08

Start date

2005-02-28

Completion date

2005-10-31

Last updated

2007-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

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.

Interventions

DRUGExtended-release carbamazepine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment	—

Secondary

Measure	Time frame
YMRS Scale	—
Clinical Global Impressions Scale - Bipolar Version	—
HAM-D and MADRS Scales for Depression	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026