Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults

Exclusion Criteria

• •1. 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;
• •2. 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;
• •3. Any unstable medical illness or laboratory abnormalities \> 3 times upper limits of normal;
• •4. 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;
• •5. Any substance use other than alcohol, nicotine, or cannabis during the 30 days prior to study participation;
• •6. A positive urine pregnancy test or lactating;
• •7. History of nephrolithiasis.
• •8. Treatment with concurrent mood stabilizers, antipsychotics or antidepressants;
• •9. Treatment with antipsychotics or other mood stabilizers within 72 hours and antidepressants within 5 days prior to randomization;
• •10. Treatment with fluoxetine within one month;
• •11. A history of non-response or hypersensitivity to quetiapine or topiramate;
• •12. 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);
• •13. Treatment for substance use during 30 days prior to screening (excluding peer support groups);
• •14. Court-ordered to substance use treatment;
• •15. Acute intoxication;
• •16. History of a medication change during the prior 30 days that may have precipitated manic symptoms;
• •17. History of a partial response (any improvement) to any existing medications as reported by treating clinician, subjects or legal guardian.