Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania - Full Text View

Sponsors and Collaborators:	University of Cincinnati National Institute on Drug Abuse (NIDA)
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00393978

Purpose

The objectives of this study are to determine whether this treatment may be useful for reducing cannabis consumption; reducing symptoms of bipolar mania; and weight mitigation therapy for individuals on psychopharmacotherapy.

Condition	Intervention	Phase
Bipolar Disorder Cannabis-Related Disorder	Drug: quetiapine + placebo Drug: Quetiapine + Topiramate	Phase IV

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: GW-1000 Topiramate Quetiapine Quetiapine fumarate Cannabis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment
Official Title:	Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Cannabis Use in Adolescents

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

To determine whether this treatment may be useful for reducing cannabis consumption. To determine whether this treatment may be useful for reducing symptoms of bipolar mania. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine whether this treatment may be useful in weight mitigation therapy for individuals on psychopharmacotherapy. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Quetiapine + Placebo vs. Quetiapine + Topiramate	Drug: quetiapine + placebo placebo (titrated to 150-300 mg/day) in combination with Quetipaine (titrated to 400-800 mg/day). Drug: Quetiapine + Topiramate topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Detailed Description:

The purpose of this research study is to study the effects (both good and bad) of combining medicines, called quetiapine and topiramate, for treating your symptoms, and other children and adolescents' symptoms, of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior). It is estimated that 1% of the population of adolescents in the United States has bipolar disorder. The purpose of this research study is also to study the effects (both good and bad) of combining the same two medicines, quetiapine and topiramate, for reducing your use, and other children and adolescents' use, of cannabis (commonly referred to as "pot"). It is estimated that 30.5% of adolescents in the United States have used cannabis at least once in their lifetime. Additionally, the purpose of this research is to look at how bipolar disorder and cannabis use effects brain chemicals and function.

Quetiapine (marketed under the brand name Seroquel) has been approved by the FDA since 1997 to help adults who suffer from schizophrenia (an illness of feeling, thought, perception and behavior). On January 12, 2004, the FDA approved quetiapine for the treatment of bipolar symptoms in adults. Quetiapine is not approved by the FDA for use in children and adolescents who have bipolar disorder. Bipolar disorder is an illness characterized by recurrent mood swings including mania (i.e., periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and clinical depression (i.e., a depressed mood, loss of interest in activities and disruption of sleep, appetite and energy). This study is being carried out to see if quetiapine is effective and safe for treatment of children and adolescents who have the symptoms of bipolar mania. This study is also being carried out to see if quetiapine, in combination with topiramate, will further reduce bipolar mania and reduce cannabis use.

Topiramate (marketed under the brand name Topomax) is approved by the U.S. FDA for the prevention of migraine headaches in adults. The FDA has also approved topiramate for epilepsy (a seizure disorder) and for use as adjunctive therapy (meaning in combination with other medicines) for partial onset seizures in adults. Topiramate is not approved by the FDA for use in adults or for use in children and adolescents who have bipolar disorder. This study is being done to see if topiramate, in combination with quetiapine, will reduce bipolar mania and reduce cannabis use.

The FDA has declared research studies with MRI field strengths up to and including 8 Tesla (a measure of field strength) as non-significant risk. This research study uses an MRI with a field strength of 4 Tesla.

Eligibility

Ages Eligible for Study:	12 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

have an authorized parent/legal guardian who understands the nature of the study and who provides written informed consent. Additionally, each subject must provide assent to the study;
be fluent in English;
be 12 to 20 years of age, inclusive;
be using a medically accepted means of contraception (i.e., oral contraceptives, medroxyprogesterone acetate injectable suspension, abstinence) if female and of menarche;
have a diagnosis of bipolar I disorder in a current manic or mixed episode, in addition to a cannabis use disorder (which includes abuse or dependence) within 28 days prior to screening, as determined by the WASH-U-KSADS;
have an initial YMRS total score of >16 at screening and baselines.

Exclusion Criteria:

have a diagnosis of mental retardation, as defined by the Weschler Abbreviated Scale of Intelligence (WASI)38 score of <70;
are acutely intoxicated, and thus impaired;
have manic or depressive symptoms resulting entirely from acute medical illness or acute intoxication or withdrawal from drugs or alcohol, as determined by medical evaluation and rapid symptom resolution;
have clinically significant alcohol or other drug withdrawal symptoms, as determined by vital signs, The Clinical Institute Withdrawal Assessment for Alcohol Scale - Revised (CIWA-Ar)24, and physician interview;
have any unstable medical or neurological illness;
have laboratory abnormalities >3 times upper limits of established normal values;
as females, have a positive urine pregnancy test, are lactating, or are not practicing a reliable form of birth control;
have a history of nephrolithiasis, since topiramate has been associated with an elevated risk of kidney stones;
have concurrent treatment with mood stabilizers, anticonvulsants, psychostimulants, or antidepressants, so that we can examine the effects of topiramate vs. placebo in combination with QT in a controlled study
have significant suicidal ideation, as defined by a score of > 3 on the Children's Depression Rating Scale-Revised CDRS34 suicide item, or any serious suicide attempt within the prior 60 days as judged by the investigator so that we do not include patients with a high risk for suicide attempts during study participation
have been treated for a substance use disorder during 28 days prior to screening or are court-ordered to treatment for substance use to ensure that, if we detect a change in use with topiramate treatment, it is likely not due to these other confounding factors that might influence substance use.

Peer support groups are not considered treatment for substance use. **Patients can be enrolled into the study that are already enrolled in a court ordered substance treatment, for at least 1 month prior to study enrollment, if they still meet the minimum cannabis use criterion.**• have been diagnosed or treated for an eating disorder, to make sure any weight loss does not contribute to an already underlying condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393978

Contacts

Contact: Jen Bell, BA

513-558-6195

jennifer.bell@psychiatry.uc.edu

Locations

United States, Ohio
University of Cincinnati Medical Center	Recruiting
Cincinnati, Ohio, United States, 45219-0516
Contact: Jennifer Bell 513-558-6195 Jennifer.Bell@psychiatry.uc.edu
Contact: Dana Goller, RN 513-558-4812 Dana.Goller@psychiatry.uc.edu
Principal Investigator: Melissa P DelBello, MD

Sponsors and Collaborators

University of Cincinnati

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Melissa P DelBello, MD

University of Cincinnati

More Information

No publications provided

Responsible Party:	University of Cincinnati ( Melissa P. DelBello, MD )
Study ID Numbers:	NIDA
Study First Received:	October 30, 2006
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00393978 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

Bipolar mania
Cannabis consumption

Study placed in the following topic categories:

Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Antipsychotic Agents
Marijuana Abuse
Neuroprotective Agents
Anti-Obesity Agents

Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Mood Disorders
Substance-Related Disorders
Topiramate
Psychotic Disorders
Anticonvulsants

Additional relevant MeSH terms:

Tranquilizing Agents
Disease
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Antipsychotic Agents
Protective Agents
Neuroprotective Agents
Marijuana Abuse
Pharmacologic Actions

Anti-Obesity Agents
Affective Disorders, Psychotic
Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Substance-Related Disorders
Topiramate
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009