Bipolar DisorderPhase 4NCT00550394
Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults
A Phase 4 study testing Quetiapine and Topiramate in people with Bipolar Disorder and Alcohol Abuse, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Bipolar Disorder, Alcohol Abuse
- What is being tested?
- Quetiapine and Topiramate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 12-25 years;
- DSM-IV-TR83 criteria for bipolar disorder, type I, manic or mixed episode;
- Young Mania Rating Scale (YMRS)86-88 score of > 16 at screening and baseline visits;
- DSM-IV-TR83 criteria for current alcohol abuse or dependence;
- Drinking >8 drinks in 30 days within the previous 6 months while meeting DSM-IV criteria for alcohol abuse or dependence.
- One standard drink is defined as 0.35 liters of beer, 0.15 liters of wine, or 0.04 liters of 80-proof liquor;
- Fluent in English;
- Provision of written informed consent/assent; 8) If female and of child bearing potential, agrees to use one of the following method of birth control: complete abstinence, barrier (diaphragm or condom), or oral contraceptive containing > 35 micrograms of ethinyl estradiol (because concomitant use of topiramate and lower estrogen oral contraceptives may lead to contraceptive failure).
Who cannot join
- Manic symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation and rapid symptom resolution;
- Clinically significant alcohol or drug withdrawal symptoms that have the potential to cause serious consequences as determined by vital signs, the CIWA-Ar,84 and medical evaluation;
- Any unstable medical illness or laboratory abnormalities > 3 times upper limits of normal;
- A documented history of mental retardation or an IQ total score < 70 as determined by the Wechsler Abbreviated Scale of Intelligence (WASI),154 administered by a trained psychometrician;
- Any substance use other than alcohol, nicotine, or cannabis during the 30 days prior to study participation;
- A positive urine pregnancy test or lactating;
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- History of nephrolithiasis.
- Treatment with concurrent mood stabilizers, antipsychotics or antidepressants;
- Treatment with antipsychotics or other mood stabilizers within 72 hours and antidepressants within 5 days prior to randomization;
- Treatment with fluoxetine within one month;
- A history of non-response or hypersensitivity to quetiapine or topiramate;
- Serious suicidal ideation (> 3 on the CDRS-R89 suicide item, or any serious suicide attempt within the prior 60 days as judged by the investigator; 3=has thoughts about suicide or hurting themselves usually when angry);
- Treatment for substance use during 30 days prior to screening (excluding peer support groups);
- Court-ordered to substance use treatment;
- Acute intoxication;
- History of a medication change during the prior 30 days that may have precipitated manic symptoms;
- History of a partial response (any improvement) to any existing medications as reported by treating clinician, subjects or legal guardian.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45227
About this study
Official title: Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Alcohol Use in Adolescents & Young Adults
The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study the effects (both good and bad) of combining quetiapine and topiramate for reducing use of alcohol.
Read the detailed description
Specific Aim 1: To collect preliminary data regarding the efficacy and tolerability of topiramate for the treatment of alcohol use disorders (alcohol abuse and dependence) in adolescents with bipolar disorder.
Hypothesis 1: We hypothesize that topiramate in combination with quetiapine will lead to greater reduction in alcohol consumption (number of drinks per day, number of drinks per drinking day, and number of heavy drinking days) and greater abstinence (percentage of days abstinent) compared with quetiapine alone.
Specific Aim 2: To obtain preliminary data regarding the efficacy of topiramate for reducing manic symptoms in adolescents with co-occurring alcohol use and bipolar disorders.
Hypothesis 2: We hypothesize that the topiramate in combination with quetiapine will produce greater reduction in Young Mania Rating Scale (YMRS) scores than quetiapine alone.
- Conditions
- Bipolar Disorder, Alcohol Abuse
- Being tested
- quetiapine and placebo, Quetiapine and Topiramate
- Keywords
- Adolescents
- Medical subject headings
- Bipolar Disorder, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapine and placeboDrug
Also called Quetiapine
Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.
Quetiapine and TopiramateDrug
Also called Topiramate
Dosing Schedule and Titration of Quetiapine:
open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine and Placebo | Active comparator | Quetiapine and Placebo Receives: Drug: quetiapine and placebo |
| Quetiapine and Topiramate | Experimental | Quetiapine and Topiramate Receives: Drug: Quetiapine and Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks Per Day
Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period).
Measured: baseline to 12 weeks or endpoint (up to 11 weeks)
Drinks Per Drinking Day
Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period)
Measured: baseline to 12 weeks or endpoint (up to 11 weeks)
Percentage of Days Abstinent
Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period).
Measured: baseline to 12 weeks or endpoint (up to 11 weeks)
Percent Heavy Drinking Days
Change in percent heavy drinking days (number of days of > 4 drinks/day divided by number of days in that study period).
Measured: baseline to 12 weeks or endpoint (up to 11 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startApr 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Melissa Delbello, University of Cincinnati
- Investigators
- Melissa P DelBello, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550394
- Sponsor's protocol ID
- NIAAA
- Other IDs
- R21AA016372
- Status last verified
- Oct 2014
- First submitted
- 25 Oct 2007
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Alcohol Use in Adolescents & Young Adults
- ClinicalTrials.gov ID
- NCT00550394
- Acronym / sponsor ID
- NIAAA
- Conditions
- Bipolar Disorder, Alcohol Abuse
- Keywords
- Adolescents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Oct 2007 (estimated)
- Results
- Posted 23 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study the effects (both good and bad) of combining quetiapine and topiramate for reducing use of alcohol.
Detailed description
Specific Aim 1: To collect preliminary data regarding the efficacy and tolerability of topiramate for the treatment of alcohol use disorders (alcohol abuse and dependence) in adolescents with bipolar disorder.
Hypothesis 1: We hypothesize that topiramate in combination with quetiapine will lead to greater reduction in alcohol consumption (number of drinks per day, number of drinks per drinking day, and number of heavy drinking days) and greater abstinence (percentage of days abstinent) compared with quetiapine alone.
Specific Aim 2: To obtain preliminary data regarding the efficacy of topiramate for reducing manic symptoms in adolescents with co-occurring alcohol use and bipolar disorders.
Hypothesis 2: We hypothesize that the topiramate in combination with quetiapine will produce greater reduction in Young Mania Rating Scale (YMRS) scores than quetiapine alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine and Placebo | Active comparator | Drug: quetiapine and placeboQuetiapine and Placebo |
| Quetiapine and Topiramate | Experimental | Drug: Quetiapine and TopiramateQuetiapine and Topiramate |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Ages 12-25 years;
- DSM-IV-TR83 criteria for bipolar disorder, type I, manic or mixed episode;
- Young Mania Rating Scale (YMRS)86-88 score of > 16 at screening and baseline visits;
- DSM-IV-TR83 criteria for current alcohol abuse or dependence;
- Drinking >8 drinks in 30 days within the previous 6 months while meeting DSM-IV criteria for alcohol abuse or dependence.
Key exclusion criteria (17 listed)
- Manic symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation and rapid symptom resolution;
- Clinically significant alcohol or drug withdrawal symptoms that have the potential to cause serious consequences as determined by vital signs, the CIWA-Ar,84 and medical evaluation;
- Any unstable medical illness or laboratory abnormalities > 3 times upper limits of normal;
- A documented history of mental retardation or an IQ total score < 70 as determined by the Wechsler Abbreviated Scale of Intelligence (WASI),154 administered by a trained psychometrician;
- Any substance use other than alcohol, nicotine, or cannabis during the 30 days prior to study participation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quetiapine and placeboAlso: QuetiapineDosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1 Dosing Schedule and Titration of Topiramate: All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner. Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4. | Drug | Quetiapine and Placebo |
| Quetiapine and TopiramateAlso: TopiramateDosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1 Dosing Schedule and Titration of Topiramate: All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner. Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4. | Drug | Quetiapine and Topiramate |
Primary outcome
Drinks Per Day
Time frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period).
Drinks Per Drinking Day
Time frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period)
Percentage of Days Abstinent
Time frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period).
Percent Heavy Drinking Days
Time frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Change in percent heavy drinking days (number of days of > 4 drinks/day divided by number of days in that study period).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa P DelBello, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine and Topiramate in people with Bipolar Disorder and Alcohol Abuse, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinks Per Day (time frame: baseline to 12 weeks or endpoint (up to 11 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.