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Phase 4 N=46 Diagnostic

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

Bipolar Disorder

Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: 17-item Hamilton Depression Rating Scale (HDRS) — 20; 6; 6; 2 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Lithium (Drug)
Age
Pediatric, Adult · 15+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Jan 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
17-item Hamilton Depression Rating Scale (HDRS)
20; 6; 6; 2; 3; 2
SECONDARY
Young Mania Rating Scale
15; 3; 1; 3; 2; 2

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.

Eligibility Criteria

Inclusion criteria for BD participants:

  • 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

Inclusion criteria for BD depressed participants:

  • 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

Inclusion criteria for BD (hypo) manic participants:

  • 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

Inclusion criteria for BD euthymic patients:

  • Satisfy criteria for DSM-IV for euthymic state-current for at least 2 weeks.
  • 17-item Hamilton Depression Rating Scale < 12; Young Mania Rating Scale score < 10

Exclusion criteria for BD participants:

  • 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

Inclusion criteria for first degree relatives of bipolar disorder subjects:

  • 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.
  • 17-item Hamilton Depression Rating Scale < 10; Young Mania Rating Scale score < 10

Exclusion criteria for first degree relatives of bipolar disorder subjects:

  • Under 15 years of age.
  • Meeting DSM-IV criteria for current episode of unipolar depression
  • Pregnant or breast feeding.
  • Metallic implants or other contraindication to MRI.
  • Currently taking any prescription or centrally acting medications.
  • Serious acute or chronic medical or neurological illness as assessed by history, physical examination and laboratory examination including CBC and blood chemistry.
  • Use of alcohol in the past 1 week and not being able to avoid alcohol use during the course of the study.

Inclusion criteria for healthy subjects:

  • Ages 18-60 years (inclusive) and able to give voluntary informed consent.
  • No current or past history of psychiatric illness or substance abuse or dependence.
  • No current or past history of psychiatric illness or substance abuse or dependence in a first degree relative.

Exclusion criteria for healthy participants:

  • Under 18 years of age
  • Pregnant or breastfeeding
  • Metallic implants or other contraindication to MRI
  • Significant family history of psychiatric or neurological illness
  • Currently taking any prescription or centrally acting medications
  • Serious acute or chronic medical or neurological illness as assessed by history, physical examinat
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00596622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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