Cytidine and Omega-3 Fatty Acids in Bipolar Disorder

NCT00854737 | Completed Phase 2

• 1 other identifier: 2009-P-000149
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of the proposed clinical trial is to assess the effect of oral cytidine and omega-3 fatty acids (O3FA) on bipolar disorder symptoms. This study is a 4-month, randomized, parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. During the 16 week period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids + cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo supplementation.

Conditions

Bipolar Disorder

Keywords

bipolar disorder; bipolar depression; bipolar mania; manic depression; depression; mania; hypomania

Outcome Measures

Primary Outcomes (1)

• Mood Rating Scale Scores

  weekly-biweekly

Secondary Outcomes (2)

• Study Retention Time

  4 months

• functional recovery

  weekly-biweekly

Study Arms (3)

1

ACTIVE COMPARATOR

Omega-3 fatty acid and cytidine supplementation

Dietary Supplement: cytidine; Dietary Supplement: omega-3 fatty acids

2

ACTIVE COMPARATOR

omega-3 fatty acid supplementation

Dietary Supplement: omega-3 fatty acids

placebo

PLACEBO COMPARATOR

placeno or sugar pill

Drug: placebo

Interventions

cytidine DIETARY_SUPPLEMENT

cytidine (2g po daily for 4 months)

1

omega-3 fatty acids DIETARY_SUPPLEMENT

omega-3 fatty acids (4g po daily for 4 months)

1; 2

placebo DRUG

sugar pill

Also known as: arm 2 and 3

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• bipolar disorder
• mood episode within past year
• stable medication regimen

You may not qualify if:

• primary psychiatric disorder other than bipolar disorder
• significant suicide or homicide risk
• unstable medical conditions
• current or planned pregnancy
• lactose intolerance
• medications affecting lipid absorption or metabolism
• clozapine treatment

Sponsors & Collaborators

• Mclean Hospital: lead
• Stanley Medical Research Institute: collaborator

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Related Publications (6)

• Babb SM, Appelmans KE, Renshaw PF, Wurtman RJ, Cohen BM. Differential effect of CDP-choline on brain cytosolic choline levels in younger and older subjects as measured by proton magnetic resonance spectroscopy. Psychopharmacology (Berl). 1996 Sep;127(2):88-94. doi: 10.1007/BF02805979.

  PMID: 8888372 BACKGROUND

• Babb SM, Wald LL, Cohen BM, Villafuerte RA, Gruber SA, Yurgelun-Todd DA, Renshaw PF. Chronic citicoline increases phosphodiesters in the brains of healthy older subjects: an in vivo phosphorus magnetic resonance spectroscopy study. Psychopharmacology (Berl). 2002 May;161(3):248-54. doi: 10.1007/s00213-002-1045-y. Epub 2002 Mar 22.

  PMID: 12021827 BACKGROUND

• Carlezon WA Jr, Mague SD, Parow AM, Stoll AL, Cohen BM, Renshaw PF. Antidepressant-like effects of uridine and omega-3 fatty acids are potentiated by combined treatment in rats. Biol Psychiatry. 2005 Feb 15;57(4):343-50. doi: 10.1016/j.biopsych.2004.11.038.

  PMID: 15705349 BACKGROUND

• Stoll AL, Severus WE, Freeman MP, Rueter S, Zboyan HA, Diamond E, Cress KK, Marangell LB. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1999 May;56(5):407-12. doi: 10.1001/archpsyc.56.5.407.

  PMID: 10232294 BACKGROUND

• Carlezon WA, Pliakas AM, Parow AM, Detke MJ, Cohen BM, Renshaw PF. Antidepressant-like effects of cytidine in the forced swim test in rats. Biol Psychiatry. 2002 Jun 1;51(11):882-9. doi: 10.1016/s0006-3223(01)01344-0.

  PMID: 12022961 BACKGROUND

• Murphy BL, Stoll AL, Harris PQ, Ravichandran C, Babb SM, Carlezon WA Jr, Cohen BM. Omega-3 fatty acid treatment, with or without cytidine, fails to show therapeutic properties in bipolar disorder: a double-blind, randomized add-on clinical trial. J Clin Psychopharmacol. 2012 Oct;32(5):699-703. doi: 10.1097/JCP.0b013e318266854c.

  PMID: 22926607 DERIVED

Related Links

• hospital website with links to research group and studies

MeSH Terms

Conditions

Bipolar Disorder; Depression; Mania

Interventions

Cytidine; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Beth L Murphy, MD, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 3, 2009
• Study Start: July 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: July 1, 2010
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

US (2)