A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
Condition: Amphetamine Abuse; Amphetamine Dependence; Bipolar Disorder; Major Depressive Disorder
MeSH terms: Amphetamine-Related Disorders; Depressive Disorder; Depression; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar disorder (BD) is a common and severe psychiatric illness. Drug and alcohol abuse are
      very common in people with BD and other mood disorders and are associated with increased
      rates of hospitalization, violence towards self and others, medication non-adherence and
      cognitive impairment. However, few studies have investigated the treatment of dual-diagnosis
      patients as substance use is frequently an exclusion criterion in clinical trials of patients
      with BD. To address this need, we have developed a research program that explores the
      pharmacotherapy of people with BD and substance related-disorders. A potentially very
      interesting treatment for BD is citicoline. Some data suggest that this supplement may
      stabilize mood, decrease drug use and craving, and improve memory. We found promising results
      with citicoline in patients with BD and cocaine dependence. In recent years the use of
      amphetamine and methamphetamine has become an important public health concern. However,
      virtually no research has been conducted on the treatment of amphetamine abuse. We propose a
      double-blind placebo controlled prospective trial of citicoline in a group of 60 depressed
      outpatients with bipolar disorder, depressed phase or major depressive disorder and
      amphetamine abuse/dependence, to explore the safety and tolerability of citicoline, and its
      efficacy for mood symptoms, stimulant use and craving and its impact on cognition. Our goal
      is to determine which symptoms (e.g. mood, cognition, substance use) citicoline appears to be
      most effective and estimate effect sizes for future work.
    

Detailed description: 
      Sixty outpatients meeting the inclusion and exclusion criteria will be enrolled after
      completing an Institutional Review Board (IRB)-approved informed consent process. Baseline
      evaluation will include a medical and psychiatric history, structured clinical interview for
      Diagnostic and Statistical Manual (DSM-IV) (SCID), mood assessment with the Inventory of
      Depressive Symptomatology-Self Report (IDS-C), Young Mania Rating Scale (YMRS), and cognitive
      assessment with the Hopkins Auditory Verbal Learning Test (HVLT) (similar to the Rey Auditory
      Verbal Learning Test (RAVLT) but more alternative equivalent versions are available), Stroop
      and computer assessments including Sternberg Memory Task and the Running Memory Continuous
      Performance Test. Alternate but equivalent versions of all cognitive tests, except the
      Stroop, will be used to minimize practice effects with repeated administration. Days and
      amounts of amphetamine and other substance use will be assessed at each visit with urine drug
      screens, and through self-report using the timeline follow-back method. Amphetamine, and
      other drug, craving will be assessed with a visual analogue scales. Citicoline or placebo
      add-on therapy will be given beginning at one tablet (500mg)/day with an increase to two
      tablets 1000 mg/day at week 2, three tables 1500 mg/day at week 4 and four tablets 2000
      mg/day at week 6.
    

Intervention name(s): Citicoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. Citicoline or placebo (identical in appearance) add-on therapy was given beginning at one tablet (500mg/day) with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4 and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.; Placebo matching active medication in all other physical aspects
Intervention MeSH terms: Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amphetamine Abuse; Amphetamine Dependence; Bipolar Disorder; Major Depressive Disorder; Citicoline