NCT00150605

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

November 2, 2007

Status Verified

June 1, 2006

First QC Date

September 6, 2005

Last Update Submit

November 1, 2007

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment

Secondary Outcomes (3)

  • YMRS Scale

  • Clinical Global Impressions Scale - Bipolar Version

  • HAM-D and MADRS Scales for Depression

Interventions

Extended-release carbamazepineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

February 1, 2005

Study Completion

October 1, 2005

Last Updated

November 2, 2007

Record last verified: 2006-06