N/A Completed N=91 Randomized Single-blind Other

fMRI Study of Treatment Changes in Major Depression

Source: ClinicalTrials.gov NCT01027559 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcomePrimary: Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants. — -18.74; 2.71; 316.24; 411.2 Voxels

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.	-18.74; 2.71; 316.24; 411.2; -16.82; -46.06	—
PRIMARY Hamilton Depression Rating Scale Score at Baseline and 12 Weeks	19.94; 1.38; 20.79; 5.94; 1.07; 4.43	—

Eligibility Criteria

DEPRESSED GROUP:

Inclusion criteria

Age 18-50
DSM-IV criteria for major depressive disorder (MDD)
Minimum Hamilton Rating Scale for Depression (HAMD) score > 18
Right handed
Capacity to give informed consent and follow study procedures
English speaking

Exclusion criteria

Cannot give informed consent
Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures
Does not speak English
Known primary neurological disorders
Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
MRI contraindications e.g. foreign metallic implants, pacemaker
Known allergy or hypersensitivity to sertraline
Active suicidality
Severe or unstable medical illness or conditions or drugs that may cause depression
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.
Current episode has failed to respond to adequate trials of two prior antidepressants for at least 6 weeks at therapeutic doses.
Treatment with sertraline for at least one month in past 3 months.
Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics.
Current psychotherapy
Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers.

CONTROL GROUP:

Inclusion criteria

Age 18-50
No history of MDD
HAMD score < 7
Right handed
Capacity to give informed consent and follow study procedures
English speaking

Exclusion criteria

Cannot give informed consent
Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures
Does not speak English
Known primary neurological disorders
Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
MRI contraindications e.g. foreign metallic implants, pacemaker
Severe or unstable medical illness or conditions or drugs that may cause depression
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.
Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics.
Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01027559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.