NCT00097032

Brief Summary

The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2004

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

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

May 24, 2011

Status Verified

March 1, 2010

First QC Date

November 17, 2004

Last Update Submit

May 20, 2011

Conditions

Bipolar Disorder

Keywords

Bipolar I Disorderrisperidonequetiapinesedationcognition

Outcome Measures

Primary Outcomes (1)

  • To compare the treatment effects of risperidone and quetiapine on cognitive function due to sedation

Secondary Outcomes (1)

  • To assess the association between subjective experience of sedation and cognitive function

Interventions

risperidone; quetiapineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with bipolar I disorder in partial or full remission and deemed clinically stable

You may not qualify if:

  • Current use of benzodiazepines, prescription or herbal sleep agents
  • Use of antihistamines
  • Use of antipsychotic medications in the past 6 months
  • Pregnant/breastfeeding females
  • Females not using contraception
  • Illicit drug users

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Harvey PD, Hassman H, Mao L, Gharabawi GM, Mahmoud RA, Engelhart LM. Cognitive functioning and acute sedative effects of risperidone and quetiapine in patients with stable bipolar I disorder: a randomized, double-blind, crossover study. J Clin Psychiatry. 2007 Aug;68(8):1186-94. doi: 10.4088/jcp.v68n0804.

    PMID: 17854242RESULT

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Interventions

RisperidoneQuetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2004

First Posted

November 18, 2004

Study Start

October 1, 2004

Study Completion

May 1, 2005

Last Updated

May 24, 2011

Record last verified: 2010-03