Brain Regulation of Emotions in People With Depression and Anhedonia

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00059579
• Date of registration: 29/04/2003
• Prospective Registration: No
• Primary sponsor: National Institute of Mental Health (NIMH)
• Public title: Brain Regulation of Emotions in People With Depression and Anhedonia
• Scientific title: Functional MRI Study of Brain Mechanism Mediating Anhedonia in Major Depression
• Date of first enrolment: April 24, 2003
• Target sample size: 163
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00059579
• Study type: Observational
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

- INCLUSION CRITERIA

For both patient and control groups:

Age 18 to 50 of any ethnicity without other significant medical conditions

Not in active use of illicit drugs and heavy consumption of alcohol

No metallic implants or onplants that are ferromagnetic

Competent to sign consent forms to participate in the study.

For patient groups:

For the group with significant anhedonia, current MDD, as defined by DSM-IV criteria, with
significant anhedonia defined as having PAS and/or SAS scores at or above one standard
deviation of appropriate norm. For the group without significant anhedonia, current MDD, as
defined by DSM-IV criteria, without significant anhedonia defined as having PAS and/or SAS
scores within or below one standard deviation of appropriate norm. The BPD subjects will
meet DSM-IV criteria for bipolar I or II disorder, most recent episode depressed and will
currently be in a major depressive episode. We will use the Young Mania Rating Scale to
assess the severity of the disorder Subjects may be enrolled as either inpatients or
outpatients at their entrance to the study.

For control group:

No prior history of any psychiatric conditions including substance dependence

No family history of MDD, bipolar disorder, or psychosis

PAS and/or SAS scores within or below one standard deviation of appropriate norm.

EXCLUSION CRITERIA:

Medical conditions or concomitant medications that are likely to influence cerebral blood
flow or neurological function including cardiovascular, respiratory, endocrine and
neurological diseases;

History of psychosis, current mania and substance dependence;

Exposure to psychiatric medications in the past 4 weeks;

History of repeated self-mutilation or homicidal attempts, current active suicidal /
homicidal ideations;

Current or recent (within past six weeks) illicit drug use or heavy alcohol consumption
(more than 2 six-packs of beer or equivalent alcoholic beverages per week);

Pathological gamblers as defined by DSM-IV.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Secondary ID(s)

03-M-0149

030149

Source(s) of Monetary Support

Please refer to primary and secondary sponsors