Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI

NCT01811147 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB 12-1279
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Major Depression

Keywords

Bipolar; Depression; Mania; Hypomania; fMRI; antidepressant

Outcome Measures

Primary Outcomes (1)

• HAM-D 17 Item: Hamilton Depression Rating Scale

  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

Secondary Outcomes (1)

• YMRS: Young Mania Rating Scale

  24 months

Study Arms (4)

High Risk Depression

EXPERIMENTAL

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)

Low Risk Depression

EXPERIMENTAL

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)

Healthy Control

NO INTERVENTION

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

Bipolar

NO INTERVENTION

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.

Interventions

Selective Serotonin Reuptake Inhibitor (SSRI) DRUG

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

Also known as: Serotonin-norepinephrine reuptake inhibitor

High Risk Depression; Low Risk Depression

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.
• 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
• 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
• At least one of the following:

You may not qualify if:

• 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.
• 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.
• Pregnant or breast feeding.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation Center for Behavioral Health

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Koirala P, Hu B, Altinay M, Li M, DiVita AL, Bryant KA, Karne HS, Fiedorowicz JG, Anand A. Sub-threshold bipolar disorder in medication-free young subjects with major depression: Clinical characteristics and antidepressant treatment response. J Psychiatr Res. 2019 Mar;110:1-8. doi: 10.1016/j.jpsychires.2018.12.006. Epub 2018 Dec 8.

  PMID: 30579045 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Depression; Mania

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Dr. Amit Anand
• Organization: Cleveland Clinic Foundation

ananda@ccf.org

216-636-2840

Study Officials

• Amit Anand, MD

  The Cleveland Clinic

  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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: March 14, 2013
• Study Start: November 1, 2011
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2019-11

Locations

US (1)