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Bipolar DepressionPhase 4NCT00457054

Functional Connectivity in Mood Regulating Circuit In Bipolar Depression and Mania

A Phase 4 study testing Lithium in people with Bipolar Depression, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out what parts of the brain have increased or decreased activity with individuals who have bipolar disorder and how medicine changes this activity in bipolar subjects. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Bipolar Depression
What is being tested?
Lithium
How many people
60 participants
Where
1 siteUnited States
Study dates
Jul 2003to Mar 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ages 18-60 years and able to give voluntary informed consent.
  • Satisfy criteria for Bipolar Depression using the Structured Clinical Interview for Diagnostic and Statistical Manual -4th edition (DSM-IV) (SCID-IV).
  • Bipolar depressed subjects: 25-item Hamilton Depression Rating Scale (HDRS) score > 18.Young Mania Rating Score (YMRS)<10.
  • Bipolar hypomanic/manic subjects will have a YMRS score>12 and a 25-item HDRS score<10.
  • Bipolar Euthymic subjects will have YMRS score < 10 and HDRS score < 10 and would have been euthymic for > 14 days.
  • Subjects will be drug and medication free and would have no significant history of medical or neurological illness.
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  • Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire
  • Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:
  • Symptoms not worsening by more than 10 points on either the HDRS or the YMRS during the course of the study.
  • No danger to self or others.
  • No psychotic symptoms.
  • Ages 18-60 years and able to give voluntary informed consent.
  • No history of psychiatric illness or substance abuse or dependence as assessed by SCID for non-patients (SCID-NP).
  • No significant family history of psychiatric or neurological illness.
  • Not currently taking any prescription or centrally acting medications.
  • No serious medical or neurological illness as assessed by history, physical examination and laboratory examination including CBC and blood chemistry.

Who cannot join

  • Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder.
  • Use of neuroleptic past 2 weeks
  • Use of antidepressants in the past 2 weeks. If on fluoxetine in the past then should not have been on this medication for 4 weeks.
  • Use of mood stabilizers in the past 2 weeks
  • Use of benzodiazepines in the past 2 weeks.
  • Acutely suicidal or homicidal or requiring inpatient treatment.
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  • Meeting DSM-IV criteria for other substance dependence within the past year, except caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening initially and on test days.
  • Use of alcohol in the past 1 week.
  • No serious medical or neurological illness as assessed by physical examination and laboratory examination including complete blood count (CBC) and blood chemistry.
  • Current pregnancy or breast feeding.
  • Metallic implants.
  • Previously known positive Human Immunodeficiency Virus (HIV) blood test as reported by the subject.
  • Under 18 years of age.
  • Pregnant or breast feeding.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Adult Psychiatry Clinic

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Functional Connectivity in Mood Regulating Circuit In Bipolar Depression and Mania Before and After Lithium Treatment: An Brain fMRI Study

The purpose of this study is to find out what parts of the brain have increased or decreased activity with individuals who have bipolar disorder and how medicine changes this activity in bipolar subjects. Another purpose of this study is to compare data obtained from bipolar depressed subjects with data obtained from healthy subjects. In this study we will measure activity in different parts of the brain, while participants see pictures, using Magnetic Resonance Imaging (MRI) scan. We will do two MRI scans with each subject before and after treatment for eight weeks with a standard bipolar disorder medication called lithium.

Read the detailed description

Aim 1: Our first aim is to use a novel fMRI experimental paradigm to investigate the pathophysiology of bipolar disorder (BD) in terms of the strength of connectivity (as measured by LFBF correlations) between the different emotion regulating areas of the brain rather than in terms of increase or decrease in localized brain activity.

Specific Aim 2: Our second aim is to investigate whether lithium works by altering the connectivity of areas of the brain implicated in the pathophysiology of BD, thereby leading to changes in the abnormal positive or negative emotional reactions to the environment seen in mania and depression respectively.

Specific Aim 3: Out third aim is to investigate whether patients with the s/s or s/L alleles of the 5-HTTLPR polymorphism will have greater amygdalar activation and decreased cortico-amygdala connectivity compared to patients with L/L genotype. We will also investigate whether lithium treatment differentially affects these fMRI measures in the s/s or s/L and L/L genotypes.

Methods:

We will study unmedicated subjects satisfying DSM-IV criteria for Bipolar Disorder current episode depressed or hypomanic/manic or who are euthymic. Subjects will undergo fMRI before and after 8 weeks of treatment with lithium a mood stabilizer that is known to be effective in both phases of BD. Healthy subjects will have a scan at baseline and after 8 weeks but will not be treated with any medication. We will also test for the serotonin transporter gene (the gene that controls the availability of a chemical called serotonin in the brain), which has been shown to effect how lithium works.

Being tested
Lithium
Keywords
Mood Regulating Circuit, Lithium, fMRI
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LithiumDrug

    starting dose 600 mg increase as tolerated

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparative activation of amygdala and cortico-amydalar connectivity as measured by fMRI taken at baseline and eight weeks from baseline

    Measured: 07-03 to 3-07

  2. Improvement of scores on Hamilton Depression Rating Scale given weekly for eight weeks

    Measured: 07-03 to 3-07

Secondary outcomes (2)

  1. Improvement as measured by the Clinical Global Impression Severity and Improvement Scales given weekly for eight weeks

    Measured: 07-03 to 3-07

  2. Improvement as measured by the Brief Psychiatric Rating Scale given weekly for eight weeks

    Measured: 07-03 to 3-07

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2007 (estimated)
  2. Study startJul 2003
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00457054
Sponsor's protocol ID
0303-28
Other IDs
61-869-18
Status last verified
Sep 2011
First submitted
14 Sep 2005
Last updated
28 Sep 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lithium in people with Bipolar Depression, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparative activation of amygdala and cortico-amydalar connectivity as measured by fMRI taken at baseline and eight weeks from baseline (time frame: 07-03 to 3-07). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00457054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2011.

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