- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811147
Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation Center for Behavioral Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA FOR BIPOLAR DEPRESSED PATIENTS:
- Ages 15 - 30 years (inclusive) and able to give voluntary informed consent (parents must also sign consent for subjects under 18)
- Satisfy criteria for Diagnostic and Statistical Manual 4th edition (DSM-IV-TR) for Bipolar I or II disorder
- Satisfy criteria for DSM-IV depressive episode-current
- 17-item Hamilton Depression Rating Scale > 15 but < 25;
- Young Mania Rating Scale score < 10
- Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.
- 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:
- Ages 15 - 30 years and able to give voluntary informed consent (Parental consent must also be obtained for those under 18 years old).
- Satisfy criteria for DSM-IV-TR Major Depressive Episode using a Structured Interview
- Never met criteria for mania or hypomania
- 17-item Hamilton Depression Rating Scale score (HDRS) > 15 and < 25.
- Young Mania Rating Scale (YMRS) score < 10
- Satisfy safety criteria to undergo an MRI scan
- 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:
- Family history of bipolar disorder in at least one first degree relative
- History of any sub-threshold hypomania symptoms
- History of mood episode related psychotic symptoms
ADDITIONAL INCLUSION CRITERIA FOR LOW RISK UD (HRUD) PATIENTS BESIDE THE INCLUSION CRITERIA FOR UD:
- No family history of BD in a first or a second degree relative
- No past history of any sub-threshold hypomania symptoms
- No history of psychotic symptoms
EXCLUSION CRITERIA FOR DEPRESSION AND BIPOLAR SUBJECTS:
- Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
- History of receiving electroconvulsive therapy in the past 1 year
- Use of neuroleptics, mood stabilizers or benzodiazepines in the 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 5 weeks.
- Acutely suicidal or homicidal or requiring inpatient treatment.
- 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.
- Use of alcohol in the past 1 week before the MRI scan.
- 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.
- Current pregnancy or breast feeding.
- Metallic implants or other contraindication to MRI.
INCLUSION CRITERIA FOR HEALTHY CONTROLS: Healthy subjects matched for age, gender and ethnicity will be included
- Ages 15 - 30 years (inclusive) and able to give voluntary informed consent (Parental consent must also be obtained for those under 18 years old)
- 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 CONTROLS:
- Pregnant or breast feeding.
- 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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: High Risk Depression
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.
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Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
Other Names:
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EXPERIMENTAL: Low Risk Depression
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..
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Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
Other Names:
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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HAM-D 17 Item: Hamilton Depression Rating Scale
Time Frame: 24 months
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Hamilton depression rating scale (17-item HAM-D): Scores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24). |
24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
YMRS: Young Mania Rating Scale
Time Frame: 24 months
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Young Mania Rating Scale: Scores can range from 0 to 60: In Remission/No Mania (0-8); Mild (9-12); Moderate (13-18); Severe (19-25); Very Severe (>25)
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24 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Bipolar and Related Disorders
- Depression
- Depressive Disorder
- Bipolar Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Serotonin Receptor Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Norepinephrine
- Serotonin
- Serotonin Uptake Inhibitors
Other Study ID Numbers
- IRB 12-1279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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