NCT00227123

Brief Summary

The purpose of this study is to determine whether quetiapine or risperidone are effective in treating mood symptoms, drug cravings and use in bipolar disorder with concurrent cocaine or methamphetamine dependence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

January 4, 2008

Status Verified

October 1, 2007

First QC Date

September 23, 2005

Last Update Submit

January 3, 2008

Conditions

Bipolar DisorderCocaine DependenceMethamphetamine Dependence

Keywords

Bipolar, cocaine, methamphetamine,quetiapine,risperidone

Outcome Measures

Primary Outcomes (2)

  • Mood symptom improvement.

    Baseline to exit

  • Cocaine or methamphetamine cravings and use.

    Baseline to exit

Secondary Outcomes (1)

  • Body Mass Index

    Baseline to Exit

Study Arms (1)

1

ACTIVE COMPARATOR

Quetiapine versus Risperidone

Drug: quetiapine, risperidone

Interventions

quetiapine, risperidoneDRUG

Flexible dose titrations to 'treat-to-symptoms'

Also known as: Seroquel, Risperdal
1

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • English-speaking men and women (20-50 years old) of all ethnic origins
  • Outpatients with a current DSM-IV diagnosis of bipolar I with or without psychotic features or bipolar II disorder
  • Current cocaine or methamphetamine dependence
  • Currently experiencing hypomanic, manic, or mixed state episodes with a Young Mania Rating Scale23 (YMRS11) score of \> 9
  • Currently craving stimulants with a craving score of \> 20 on the 10-item, self-reported Stimulant Craving Questionnaire24 (SCQ10)
  • A high school diploma, GED, or Shipley IQ test score of \>85.

You may not qualify if:

  • Inpatients or anyone with a high risk for suicide (i.e., active suicidal ideation with a proposed plan, history of any suicide attempt within the last 6 months)
  • DSM-IV diagnosis of substance-induced mood disorder
  • Pregnant or breast-feeding
  • History of special education, mental retardation, dementia
  • HIV/AIDS, reactive hepatitis, hepatic cirrhosis or any active liver disease, personal or familial history of diabetes, personal history of heart disease (i.e., congenital heart abnormalities, congestive heart failure, chronic atrial fibrillation, rheumatic heart disease, heart attack)
  • Central nervous system diseases (e.g., multiple sclerosis, severe head trauma, or seizures)
  • Contraindications or allergic reactions to study medications
  • Currently participating in any other research program
  • Urine positive for glucose or ketones
  • Currently receiving any antipsychotic medications or more than two psychotropic medications
  • Currently receiving benzodiazepines, sedatives or stimulants
  • Any other current substance dependence
  • Cataracts or glaucoma
  • EKG evidence of QT prolongation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Universty of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

Related Publications (1)

  • Nejtek VA, Avila M, Chen LA, Zielinski T, Djokovic M, Podawiltz A, Kaiser K, Bae S, Rush AJ. Do atypical antipsychotics effectively treat co-occurring bipolar disorder and stimulant dependence? A randomized, double-blind trial. J Clin Psychiatry. 2008 Aug;69(8):1257-66. doi: 10.4088/jcp.v69n0808.

    PMID: 18681757DERIVED

MeSH Terms

Conditions

Bipolar DisorderCocaine-Related Disorders

Interventions

Quetiapine FumarateRisperidone

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Vicki A. Nejtek, Ph.D.

    University of North Texas Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 27, 2005

Study Start

October 1, 2002

Study Completion

November 1, 2006

Last Updated

January 4, 2008

Record last verified: 2007-10

Locations

US(2)