Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2018-06-30

Brief Summary

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The purpose of the study is to find out what parts of the brain have increased or decreased activity and connectivity in individuals who have bipolar disorder, major depression, or no history of mood disorder. Another purpose of this study is to use MRI images to determine which young adults with major depression may be at greater risk for developing mild or more severe symptoms of mania which suggests a diagnosis of bipolar disorder.

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Detailed Description

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The study involves two phases, phase one includes the screening visit and MRI. The second phase, for depression participants, involves in person follow ups for up to two years. The second phase, for healthy and bipolar participants, involves phone follow ups, every three months for up to two years. The purpose of this study is listed above. We plan to enroll 200 participants total.

Conditions

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Bipolar Disorder Major Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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High Risk Depression

Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.

Group Type EXPERIMENTAL

Selective Serotonin Reuptake Inhibitor (SSRI)

Intervention Type DRUG

Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.

Low Risk Depression

Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..

Group Type EXPERIMENTAL

Selective Serotonin Reuptake Inhibitor (SSRI)

Intervention Type DRUG

Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.

Healthy Control

There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.

Group Type NO_INTERVENTION

No interventions assigned to this group

Bipolar

Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Selective Serotonin Reuptake Inhibitor (SSRI)

Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.

Intervention Type DRUG

Other Intervention Names

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Serotonin-norepinephrine reuptake inhibitor

Eligibility Criteria

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Inclusion Criteria

1. Ages 15 - 30 years (inclusive) and able to give voluntary informed consent (parents must also sign consent for subjects under 18)
2. Satisfy criteria for Diagnostic and Statistical Manual 4th edition (DSM-IV-TR) for Bipolar I or II disorder
3. Satisfy criteria for DSM-IV depressive episode-current
4. 17-item Hamilton Depression Rating Scale \> 15 but \< 25;
5. Young Mania Rating Scale score \< 10
6. Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.
7. Able to be managed as outpatients during the study as ascertained by the following - i. Clinical Global Severity Scale \< 5 i.e. moderately ill; ii. No significant suicidal or homicidal ideation or grossly disabled.

1. Ages 15 - 30 years and able to give voluntary informed consent (Parental consent must also be obtained for those under 18 years old).
2. Satisfy criteria for DSM-IV-TR Major Depressive Episode using a Structured Interview
3. Never met criteria for mania or hypomania
4. 17-item Hamilton Depression Rating Scale score (HDRS) \> 15 and \< 25.
5. Young Mania Rating Scale (YMRS) score \< 10
6. Satisfy safety criteria to undergo an MRI scan
7. Able to be managed as outpatients during the study as ascertained by the following - i. Clinical Global Severity Scale \< 5 i.e. moderately ill; ii. No significant suicidal or homicidal ideation or grossly disabled

At least one of the following:

1. Family history of bipolar disorder in at least one first degree relative
2. History of any sub-threshold hypomania symptoms
3. History of mood episode related psychotic symptoms

1. No family history of BD in a first or a second degree relative
2. No past history of any sub-threshold hypomania symptoms
3. No history of psychotic symptoms

1. Ages 15 - 30 years (inclusive) and able to give voluntary informed consent (Parental consent must also be obtained for those under 18 years old)
2. No current or past history of psychiatric illness or substance abuse or dependence.
3. No current or past history of psychiatric illness or substance abuse or dependence in a first degree relative.

Exclusion Criteria

1. Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
2. History of receiving electroconvulsive therapy in the past 1 year
3. Use of neuroleptics, mood stabilizers or benzodiazepines in the past 2 weeks.
4. Use of antidepressants in the past 2 weeks.
5. If on fluoxetine in the past, then should not have been on this medication for 5 weeks.
6. Acutely suicidal or homicidal or requiring inpatient treatment.
7. Meeting DSM-IV criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months, excluding caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening. The use of caffeine or nicotine will be recorded.
8. Use of alcohol in the past 1 week before the MRI scan.
9. No 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 including EKG, CBC and blood chemistry.
10. Current pregnancy or breast feeding.
11. Metallic implants or other contraindication to MRI.

1. Pregnant or breast feeding.
2. Metallic implants or other contraindication to MRI.
3. Significant family history of psychiatric or neurological illness.
4. Currently taking any prescription or centrally acting medications.
5. Serious acute or chronic medical or neurological illness as assessed by history, physical examination and laboratory examination including CBC and blood chemistry.
6. Use of alcohol in the past 1 week and not being able to avoid alcohol use during the course of the study.

Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes