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Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI

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ClinicalTrials.gov Identifier: NCT01811147
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Major Depression Drug: Selective Serotonin Reuptake Inhibitor (SSRI) Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI
Study Start Date : November 2011
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: High Risk Depression
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.
Drug: 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.
Other Name: Serotonin-norepinephrine reuptake inhibitor

Experimental: Low Risk Depression
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..
Drug: 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.
Other Name: Serotonin-norepinephrine reuptake inhibitor

No Intervention: 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.
No Intervention: 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.



Primary Outcome Measures :
  1. Hamilton depression rating scale [ Time Frame: 24 months ]
    Hamilton depression rating scale


Secondary Outcome Measures :
  1. Young Mania Rating Scale [ Time Frame: 24 months ]
    Young Mania Rating Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA FOR BIPOLAR DEPRESSED PATIENTS:

  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.

INCLUSION CRITERIA FOR ALL UNIPOLAR DEPRESSED PATIENTS:

  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

ADDITIONAL INCLUSION CRITERIA FOR HIGH RISK UD (HRUD) PATIENTS BESIDE THE INCLUSION CRITERIA FOR UD:

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

ADDITIONAL INCLUSION CRITERIA FOR LOW RISK UD (HRUD) PATIENTS BESIDE THE INCLUSION CRITERIA FOR UD:

  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

EXCLUSION CRITERIA FOR DEPRESSION AND BIPOLAR SUBJECTS:

  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.

INCLUSION CRITERIA FOR HEALTHY CONTROLS: Healthy subjects matched for age, gender and ethnicity will be included

  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 FOR HEALTHY CONTROLS:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811147


Locations
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United States, Ohio
Cleveland Clinic Foundation Center for Behavioral Health
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Amit Anand, MD The Cleveland Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01811147     History of Changes
Other Study ID Numbers: IRB 12-1279
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by The Cleveland Clinic:
Bipolar
Depression
Mania
Hypomania
fMRI
antidepressant
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Norepinephrine
Antidepressive Agents
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators