Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism

• Status: Withdrawn
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary specific aim is to examine the efficacy of Paliperidone extended release Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) compared to placebo in decreasing manic symptoms in patients with comorbid DSM-IV bipolar disorder and alcohol dependence. The investigators hypothesize that the Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) treated group will have a statistically significant advantage on improvement in manic symptoms. They will also have higher rate of treatment response and remission.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: Ortho-McNeil, Inc.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria: Patients will be assessed using the Mini International Neuropsychiatric Interview at baseline, which will be carried out at least three days after all acute withdrawal symptoms have cleared. Subjects who meet DSM-IV criteria for alcohol use disorder (abuse or dependence) and a concurrent bipolar I disorder, (Mixed or Mania State) and a score on the YMRS of 16 or above, and without any exclusion criteria will be recruited for the study. The following criteria must be met. A) Abstinent from alcohol not to exceed 21 consecutive days, and a score of <8 on the CIWA-Ar, [Sullivan, 1989 #1412] at the time of randomization. B) An average minimum of > 7 drinks per week for females or > 14 drinks per week for males, over a consecutive 4-week period during the 12-week period prior to baseline. C) A breath alcohol concentration (BAC) of 0 at the time of signing Informed Consent. D) Subject stable on treatment as usual medications for bipolar disorder for at least three weeks prior to randomization.

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Exclusion Criteria: Patients with the following disorders will be excluded from the study:

1) Schizophrenia, schizoaffective, and any non-bipolar psychotic disorder, unipolar major depression, primary anxiety disorders, mental retardation, and signs of impaired cognitive functioning (operationalized as a score < 25 on Folstein's Mini-Mental Status Exam). [Folstein, 1975 #1179]. 2) Current DSM-IV criteria for dependence on substances other than alcohol, cannabis, nicotine, or caffeine. 3) Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or documented focally abnormal electroencephalograph examination (EEG), or recent history (within the past two years) of alcohol withdrawal seizure. 4) Medical conditions including severe cardiac, liver, kidney, endocrine (e.g. diabetes), hematologic (e.g. porphyria or any bleeding abnormalities), or other impairing medical conditions, or impending surgery. 5) Congenital prolongation of the QT interval (congenital long QT syndrome), and a history of cardiac arrhythmias or other conditions that prolong the QT interval such as bradycardia; hypokalemia or hypomagnesemia; or on concomitant medications known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval. 6) Persistent elevation of liver function enzymes indicating active liver disease (elevated t. bilirubin > 1.5 mg/dl, or elevation to three-time normal range of liver enzymes, SGOT, SGPT, or g-GTP). 7) Any medication that is effective for alcohol dependence such as disulfiram, naltrexone, acamprosate, or topiramate. Carbamazepine for potential clinically significant drug-drug interaction. Other exclusion criteria include pregnancy, women who are breastfeeding, inability or unwillingness to use contraceptive methods, and inability to read or understand study forms and agrees to informed consent, or based on the judgment of the investigative team that the study may not be in the best interest of the subject either due to additional safety concerns or other factors that may interfere with study participations.

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