FMRI Study of Brain Response Before and After Lithium Treatment in People With Bipolar Disorder

NCT00596622 | Completed Phase 4 Results

• 3 other identifiers: R01MH0750250607-23DATR A3-NSS
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the effects of bipolar disorder on brain activity and will determine if medication changes the brain activity in people with bipolar disorder.

Conditions

Bipolar Disorder

Keywords

Major Depressive or Manic Episodes; Bipolar; Mania; Depression; Lithium; fMRI; Pictures; Brain Scan

Outcome Measures

Primary Outcomes (1)

• 17-item Hamilton Depression Rating Scale (HDRS)

  17-item HDRS is gold standard for measurement of depression with a range from 0 - 52. 10 - 14: mild depression; 14-20 moderate depression; \>20: severe and very severe depression.

  Measured at Baseline and after 8 weeks of treatment

Secondary Outcomes (1)

• Young Mania Rating Scale

  Baseline and 8 weeks

Study Arms (3)

Bipolar Manic Subjects Treated

EXPERIMENTAL

Bipolar mania picture response during fMRI before and after treatment with lithium

Drug: Lithium

Bipolar Depressed Subjects Treated

EXPERIMENTAL

Bipolar depression picture response during fMRI before and after treatment with lithium

Drug: Lithium

Bipolar Euthymic Subjects Treated

EXPERIMENTAL

Bipolar euthymia picture response before and after treatment with lithium

Drug: Lithium

Interventions

Lithium DRUG

Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.

Bipolar Depressed Subjects Treated; Bipolar Euthymic Subjects Treated; Bipolar Manic Subjects Treated

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Meets DSM-IV criteria for bipolar I or II disorder
• Meets criteria to undergo an MRI scan based on MRI screening questionnaire
• Suited for outpatient care during the study as ascertained by a score of less than 5 on the Clinical Global Severity Scale, no significant suicidal or homicidal ideation, and no severe disability
• Meets criteria for DSM-IV depressive episode-current
• Score of greater than 15 but less than 30 on the 17-item HDRS
• Score of less than 12 on the Young Mania Rating Scale
• Meets criteria for DSM-IV manic episode-current
• Score of less than or equal to 18 on the 17-item HDRS
• Score of greater than 12 but less than 25 on the Young Mania Rating Scale
• Satisfy criteria for DSM-IV for euthymic state-current for at least 2 weeks.
• item Hamilton Depression Rating Scale \< 12; Young Mania Rating Scale score \< 10

You may not qualify if:

• Meets DSM-IV criteria for unipolar depression, schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, anxiety disorder as a primary diagnosis, mental retardation, or personality disorder
• Received electroconvulsive therapy in the 12 months prior to study entry
• Use of neuroleptics, mood stabilizers, or benzodiazepines in the 2 weeks prior to study entry
• Use of antidepressants in the 2 weeks prior to study entry
• Use of fluoxetine in the 5 weeks prior to study entry
• Use of lithium in the 6 months prior to study entry
• Acutely suicidal or homicidal or requiring inpatient treatment
• Meets DSM-IV criteria for substance/alcohol dependence, excluding caffeine or nicotine, in the 6 months prior to study entry or substance/alcohol abuse in the 3 months prior to study entry
• Use of alcohol in the 1 week prior to study entry and refusal to avoid alcohol use during the course of the study
• Presence of serious acute or chronic medical or neurological illness, including previously known HIV positive status (due to possible CNS involvement) as assessed by history, physical examination, and laboratory examination
• Pregnant or breastfeeding
• Metallic implants or other contraindication to MRI
• Ages 15-60 years (inclusive) and able to give voluntary informed consent.
• Have never satisfied criteria for DSM-IV BD.
• Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Indiana University Psychiatric Clinic

Indianapolis, Indiana, 46222, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mania; Depression

Interventions

Lithium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Small number of subjects

Results Point of Contact

• Title: Amit Anand
• Organization: Indiana University School of Medicine

aanand@iupui.edu

3172747422

Study Officials

• Amit Anand, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: August 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 17, 2016
• Results First Posted: October 17, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)