An Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Cocaine Dependence

One-hundred (100) outpatients with a diagnosis of bipolar I disorder and cocaine
abuse/dependence, established by a structured clinical interview and confirmed by a
psychiatrist, will participate. Eligible participants will be given a physical exam,
including an eye exam with an ophthalmoscope to rule out serious medical illnesses and
cataracts. Additionally, medical and psychiatric histories and baseline labs, including CBC
and a liver panel will be obtained. Blood will be drawn for routine laboratory analyses
including a complete blood count (CBC) and SMA-20 at baseline and exit. Women of
childbearing potential will be given a urine pregnancy test. Baseline measures of
psychiatric symptoms will be assessed with the Hamilton Rating Scale for Depression HRSD,
Young Mania Rating Scale (YMRS), Inventory of Depression Symptomatology-Self-Report 30-item
version (IDS-SR30), and the Psychobiology of Recovery in Depression III - Somatic Symptom
Scale (PRD-III). Cocaine craving will be assessed with Cocaine Craving Questionnaire (CCQ).
Drug use will be assessed by self-report, with the Addiction Severity Index (ASI) and a
urine drug screen (UDS). Two UDSs are performed at baseline. Cocaine use in the past week
(dollar amount spent/week and days used/week) will be assessed by patient self-report. Use
of and craving for other substances (benzodiazepines, barbiturates, alcohol, opiates,
phencyclidine, and cannabis) will also be assessed by self-report of dollar amount and days
used in the past week, UDSs, and with 100-mm single item visual analog craving scales. Side
effects will be assessed with the Abnormal Involuntary Movement Scale (AIMS), the
Simpson-Angus Scale (SAS), and the Barnes Akathesia Rating Scale (BARS). Subjects will be
randomized and be titrated up to 400 mg/day with additional flexible titration after that
time to a maximum of 800 mg/day of Quetiapine or identical appearing placebo add-on therapy
in a double- blind fashion for 12 weeks. At each weekly assessment subjects will be
evaluated with the HRSD17, IDS-R30, YMRS, CCQ, and a UDS, and receive an upward titration of
the study drug. The ASI will be repeated every four weeks. Further, participants will return
one additional time each week for a UDS. At the end of the study an unblinded psychiatrist
will provide standard open label treatment with Quetiapine until the participants can be
transferred back to their usual treatment facility. Follow up and after care arrangements
will be made for each participant near completion of the study.