fMRI Study of Treatment Changes in Major Depression

NCT ID: NCT01027559

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2014-01-31

Brief Summary

The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT) has the same healing effect on the brain for people with depression as traditional antidepressants do, and in comparison to healthy controls with no history of depression, to find out more about the causes of depression including differences in the extent of problems caused by depression. We hypothesize that CBT will have the same healing effect on the brain as antidepressants; that differences in brain activations created by the various tasks and genetic differences will help us understand differences in the type and severity of symptoms among the depressed subjects.

Detailed Description

The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT) has the same healing effect on the brain for people with depression as traditional antidepressants do, to find out more about the causes of depression and why people differ in the extent of problems caused by depression, and to determine if certain differences in genes within populations are related to clinical symptoms.Genes we are examining for this study are COMT, BDNF, and 5-HTT long arm and short arm, as well as future genes that may be discovered to play a role in depression at a later time, and will be determined by examining saliva and blood samples. We are primarily studying depression by functional Magnetic Resonance Imaging (fMRI) which allows us to identify certain parts of the brain that show how the brain works in controlling negative feelings. Participants will be imaged while performing different tasks that are believed to activate emotional circuitry of the brain. Comparisons of activation patterns across these tasks will be used to characterize the cognitive mechanisms supported by different cortical regions, and to determine patterns of functional brain deficits in subjects with depression. Comparisons will also be made between changes that occur after treatment with an approved antidepressant and treatment with CBT.

Conditions

Major Depression; Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Depressed Group: CBT

Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed.

Healthy Control Group

Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Depressed Group: SRT

Depressed participants randomized to receive the antidepressant sertraline (SRT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.

Group Type: ACTIVE_COMPARATOR

Sertraline

Intervention Type: DRUG

Depressed participants will be randomized to SRT or CBT treatment. For those in the SRT treatment condition, visits will involve dispensing medications, checking for side effects and administering the Hamilton Depression rating scale occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response. Depressed subjects will start their SRT treatment once their first MRI and computer testing sessions are completed.

Interventions

Sertraline

Depressed participants will be randomized to SRT or CBT treatment. For those in the SRT treatment condition, visits will involve dispensing medications, checking for side effects and administering the Hamilton Depression rating scale occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response. Depressed subjects will start their SRT treatment once their first MRI and computer testing sessions are completed.

Intervention Type: DRUG

Cognitive Behavioral Therapy

Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed.

Intervention Type: BEHAVIORAL

Other Intervention Names

SRT; CBT

Eligibility Criteria

Inclusion Criteria

1. Age 18-50

2. DSM-IV criteria for major depressive disorder (MDD)

3. Minimum Hamilton Rating Scale for Depression (HAMD) score > 18

4. Right handed

5. Capacity to give informed consent and follow study procedures

6. English speaking

1. Age 18-50

2. No history of MDD

3. HAMD score < 7

4. Right handed

5. Capacity to give informed consent and follow study procedures

6. English speaking

Exclusion Criteria

1. Cannot give informed consent

2. Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures

3. Does not speak English

4. Known primary neurological disorders

5. Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)

6. MRI contraindications e.g. foreign metallic implants, pacemaker

7. Known allergy or hypersensitivity to sertraline

8. Active suicidality

9. Severe or unstable medical illness or conditions or drugs that may cause depression

10. Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, psychotic features of depression, current obsessive compulsive disorder (OCD) or panic disorder. In general, subjects with a history of other Axis I disorders prior to their depression will be excluded.

11. Current episode has failed to respond to adequate trials of two prior antidepressants for at least 6 weeks at therapeutic doses.

12. Treatment with sertraline for at least one month in past 3 months.

13. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics.

14. Current psychotherapy

15. Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers.

CONTROL GROUP:

1. Cannot give informed consent

2. Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures

3. Does not speak English

4. Known primary neurological disorders

5. Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)

6. MRI contraindications e.g. foreign metallic implants, pacemaker

7. Severe or unstable medical illness or conditions or drugs that may cause depression

8. Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, major depression, OCD or panic disorder.

9. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics.

10. Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvette I Sheline, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Charles Conway, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

R01MH064821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2R01MH064821-05A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DDTR A3-NSI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

081348

Identifier Type: -

Identifier Source: org_study_id