| Ad Title: |
Citicoline for Bipolar 1 Disorder and Cocaine Dependence |
| Study Title: |
Citicoline for Bipolar 1 Disorder and Cocaine Dependence |
| Protocol Number: |
122007-039 |
| Department(s) involved in the Study: |
Psychiatry
|
| Purpose of the Study: |
The primary aim of this study is to determine citicoline treatment is associated with less cocaine use than placebo in outpatients with bipolar 1 disorder and cocaine dependence. The second aim of the study is to determine if citicoline treatment is associated with greater improvement in executive functioning than placebo in outpatients with bipolar 1 disorder and cocaine dependence. |
| Participant Eligibility: |
- Outpatients with a diagnosis of bipolar I disorder on the SCID and confirmed by interview with PI or co-I.
- Current diagnosis of cocaine dependence, cocaine use (by self-report) within 7 days prior to baseline, and a cocaine-positive urine at baseline.
- Current mood state of depressed or mixed (depression plus mania) based on SCID interview using DSM-IV criteria.
- Baseline HRSD17 score < 35 and YMRS score < 35.
- On a stable medication regimen that may include mood stabilizers, antidepressants or other psychotropic medications (e.g. lithium, divalproex/valproic acid) for at least 28 days.
- Age 18-65 years old.
- Men and women.
- English speaking individual, who can also read English. The neurocognitive measures used in this study are not available in any other languages, and must be read by the patient. There is no ability to collect this data in another manner; therefore people unable to read English may not be enrolled for participation in this study. |
| Disease/Condition Under Study: |
Bipolar disorder
Cocaine dependence |
| Cancer Related Study: |
No
|
| Study Drug(s): |
Cognizin (Citicoline)
|
| Study Device(s): |
|
| Study Doctor: |
Dr. Edson Brown |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
Aston Ambulatory Care Center
|
No
|
|
General Clinical Research Center, UT Southwestern Medical Center
|
Yes
|
|
| Contact Phone: |
214_645_6950 |
| Email: |
Sherwood.Brown@Utsouthwestern.Edu |
| Other Information: |
Criteria for Exclusion of Subjects:
. Bipolar disorders other than bipolar I based on the SCID and confirmed through clinical assessment by PI or co-I.
. Mental retardation or other severe cognitive impairment, prison or jail inmates, pregnant or nursing women, or women of childbearing age who will not use hormonalcontraceptives, abstinence, or other acceptable methods of birth control during the study.
. Currently experiencing psychotic features.
. Initiation of antidepressants, mood stabilizers, or psychotherapy within the past 28 days.
- High risk for suicide, defined as any suicide attempt in the past 6 months, or current suicidal ideation with plan and intent.
- Intensive outpatient treatment for substance abuse (however, AA, NA meetings, or weekly therapy/counseling for bipolar disorder or substance use for at least 28 days prior to randomization will be encouraged).
- Severe or life-threatening medical condition.
- Drug of choice is not cocaine.
|
| Website Keywords: |
Psychiatry
|
| Medical Keywords: |
Bipolar disorder, Cocaine dependence
|
