CoQ10 in Geriatric Bipolar Depression

NCT00720369 | Completed Results DMC

• 1 other identifier: 2008-P-000738/1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to study and compare measures of brain energy metabolism in geriatric bipolar individuals and healthy older adults. We would also like to investigate changes in brain energy metabolites and in vivo creatine kinase (CK) enzymatic activity associated with CoQ10 administration in older bipolar individuals.

Conditions

Bipolar Depression

Keywords

Bipolar depression; elderly; Coenzyme Q10; Magnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (1)

• We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI).

  The rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr \<---\> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.

  8 week trial

Secondary Outcomes (1)

• We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.

  8 week trial

Study Arms (2)

CoEnzyme Q10

EXPERIMENTAL

Open Label Study

Drug: CoEnzyme Q10

Healthy Controls

NO INTERVENTION

Healthy controls completed all study procedures completed by the CoQ10 group but did not receive any study medication.

Interventions

CoEnzyme Q10 DRUG

CoEnzyme Q10 with dosage range from 400 mg to 1200 mg per day

CoEnzyme Q10

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Meet DSM-IV diagnostic criteria for Bipolar Disorder, Current Episode Depressed
• Montgomery Asberg Depression Rating Scale (MADRS) Score of \>20
• If the MADRS score is \<20 but \>16, a diagnosis of bipolar disorder, current episode depressed, based on the Structured Clinical Interview of DSM IV TR (SCID) and Dr. Forester's initial interview would allow the subject to be included in the study.
• Young Mania Rating Scale (YMRS) Score of \< 6
• If the YMRS score is \>6 subjects can still be admitted if subjects do not meet clinical criteria for mania or hypomania at the time of screening
• Able to provide informed consent
• Must speak English
• Must be able to visit McLean Hospital for the screening visit and six study visits during the 8-week duration of the study
• Subjects may be taking other medications for bipolar depression including antidepressants, mood stabilizers and antipsychotic mediations prior to Co-Q10 therapy, but may not have any dosage adjustments of these medications in the week before Co-Q10 is added.

You may not qualify if:

• Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
• History of seizure disorder,
• History or current diagnosis of the following psychiatric illnesses: any organic mental disorder (including dementia), schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specified, unipolar major depressive disorder, patients with substance dependence disorders, including alcohol, active within the last 12 months.
• History of drug hypersensitivity or intolerance to Coenzyme Q10.
• Use of medications that are excluded in this study (barbiturates; however, the use of non-benzodiazepine sedative hypnotics (such as zolpidem (Ambien)) may be used as needed except within 12 hours of the MRI scan)
• Benzodiazepines may be used by subjects throughout the study as long as they are not taken within 12 hours of any MRI scan.
• Subjects diagnosed with a mitochondrial disorder.
• Subjects taking other putative mitochondrial enhancers (e.g., vitamin E, carnitine, creatine, Vitamin complex B, pramipexole) at the time of study entry.

Sponsors & Collaborators

• Mclean Hospital: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Cara McCabe, BA
• Organization: McLean Hospital

cfmccabe@partners.org

617-855-2410

Study Officials

• Brent P Forester, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mood Disorders Division, Geriatric Psychiatry Research Program

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 13, 2014
• Results First Posted: January 13, 2014

Record last verified: 2013-11

Locations

US (1)