Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223236
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2005-09-15
Brief Title:
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine AbuseDependence
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Double-blind Placebo-controlled Trial of Citicoline add-on Therapy in Patients With a History of Mania or Hypomania and Cocaine AbuseDependence
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder a mental disorder marked by alternating periods of mania and depression or schizoaffective disorderbipolar type a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms and cocaine abusedependence This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition the mental faculty of perception reasoning and judgement in these patients
Detailed Description:
Forty-four outpatients meeting the inclusion and exclusion criteria were enrolled after completing an Institutional Review Board IRB-approved informed consent process Baseline evaluation included a medical and psychiatric history structured diagnostic interview using Diagnostic and Statistical Manual DSM-IV criteria mood assessment with the Inventory of Depressive Symptomatology-Self Report IDS-SR Young Mania Rating Scale YMRS and cognitive assessment with the Rey Auditory Verbal Learning Test RAVLT Alternate but equivalent versions of the RAVLT were used to minimize practice effects with repeated administration Cocaine use was assessed at each biweekly visit with urine drug screens Citicoline or placebo was given beginning at one tablet 500 mgday with an increase to two tablets 1000 mgday at week 2 three tablets 1500 mgday at week 4 and four tablets 2000 mgday at week 6 Doses were decreased if needed due to side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None