NCT00719706

Brief Summary

The primary objective of this 15-week clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 18, 2012

Completed
Last Updated

July 18, 2012

Status Verified

June 1, 2012

Enrollment Period

2.7 years

First QC Date

July 18, 2008

Results QC Date

June 13, 2012

Last Update Submit

June 13, 2012

Conditions

Bipolar Depression

Keywords

Bipolar disorderBipolar depressionNatural substancesDepression

Outcome Measures

Primary Outcomes (4)

  • The 25-Item Hamilton Depression Rating Scale.

    Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.

    Baseline to 15 Weeks

  • The Montgomery-Asberg Depression Rating Scale

    Scores could range from 0 - 60 units on a scale with 0 representing the least number of depressive symptoms and 60 representing the most number of depressive symptoms.

    Baseline to 15 weeks

  • The Young Mania Rating Scale

    The scores could range from 0 - 60 units on a scale with 0 representing the least number of manic symptoms and 60 representing the most number of manic symptoms.

    Baseline to 15 weeks

  • Clinical Global Impression-Severity

    Scores could range from 0 - 7 units on a scale, with 0 representing the least severe ("Normal, not at all ill") and 7 representing the most severe ("Among the most extremely ill patients").

    Baseline to 15 weeks

Secondary Outcomes (1)

  • Phosphorus MRS Scans on 4T Scanner

    Baseline to 12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid

Drug: acetyl-l-carnitine PLUS alpha-lipoic acide

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

acetyl-l-carnitine PLUS alpha-lipoic acideDRUG

1000-3000 mg/day of acetyl-l-carnitine in addition to 600-1800 mg/day of alpha-lipoic acid.

1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female age 18-65 years.
  • Meets DSM-IV criteria for Bipolar Disorder, type I with current episode depressed.
  • Current score of greater than or equal to 18 on the 21-Item Hamilton Depression Rating Scale at Visits 1 and 2.
  • Maintained on a stable treatment regimen with no changes in medication dosages for at least two weeks prior to study entry.

You may not qualify if:

  • Unwilling or unable to provide informed consent
  • Score of greater than or equal to 12 on the Young Mania Rating Scale at Visit 1 or 2.
  • Current suicidal or homicidal ideation.
  • Active psychotic symptoms.
  • Lifetime history of schizophrenia or obsessive-compulsive disorder.
  • DSM-IV diagnosis of alcohol or substance dependence in the 3 months prior to screening.
  • Clinically significant medical condition that would interfere with study participation.
  • History of hypersensitivity to ACLCAR or ALA.
  • Pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CarnitineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Results Point of Contact

Title
Dr. Brian Brennan
Organization
McLean Hospital
bbrennan@partners.org
617-855-2911

Study Officials

  • Brian P Brennan, MD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Translational Neuroscience Research

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 22, 2008

Study Start

August 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 18, 2012

Results First Posted

July 18, 2012

Record last verified: 2012-06

Locations

US(1)