Functional Connectivity in Mood Regulating Circuit In Bipolar Depression and Mania

NCT00457054 | Completed Phase 4

• 2 other identifiers: 0303-2861-869-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Depression

Keywords

Mood Regulating Circuit; Lithium; fMRI

Outcome Measures

Primary Outcomes (2)

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

  07-03 to 3-07

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

  07-03 to 3-07

Secondary Outcomes (2)

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

  07-03 to 3-07

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

  07-03 to 3-07

Interventions

Lithium DRUG

starting dose 600 mg increase as tolerated

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University Adult Psychiatry Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Amit Anand, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: April 5, 2007
• Study Start: July 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: September 28, 2011

Record last verified: 2011-09

Locations

US (1)