Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation

Launched by MCLEAN HOSPITAL · Feb 1, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring how a specific medication might help improve decision-making processes in people who are unmedicated and struggling with major depressive disorder (MDD) or anxiety disorders. The researchers want to see if this medication can help balance certain brain functions that affect how we approach or avoid situations, which can be particularly challenging for those with these mental health conditions.

To participate, individuals aged 18 to 65 with a diagnosis of MDD or anxiety disorders must not be taking any psychiatric medications for a certain period before the study. They should be right-handed and own a smartphone, as this will be used to gather information throughout the trial. There will also be a group of healthy participants who meet specific criteria, such as not having any medical or mental health issues. If someone decides to take part in this study, they can expect to undergo assessments and evaluations to understand how the medication affects their behaviors and brain activity. It’s important to know that the trial is not yet recruiting participants, but it aims to provide valuable insights into how treatment can be improved for those with depression and anxiety.

Gender

ALL

Eligibility criteria

• Inclusion criteria for MDD/anxiety disorder group:
• • DSM-5 diagnostic criteria for MDD, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, Post Traumatic Stress (diagnosed using the SCID-5)
• • Written informed consent
• • For MDD subjects, a baseline Hamilton Depression Rating Scale score \> 16 (17-item version)
• • Right-handed
• • Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)
• • Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine, 6 months for neuroleptics, 2 weeks for benzodiazepines, 2 weeks for any other antidepressants)
• Inclusion criteria for healthy controls:
• • Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (diagnosed using the SCID-5)
• • Written informed consent
• • Right-handed
• • Absence of any medications for at least 3 weeks
• • Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)
• Exclusion criteria for all participants:
• • Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician
• • Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception
• • Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
• • History of seizure disorder
• • History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder, patients with mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse; which will lead to exclusion)
• • History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
• • History of use of dopaminergic drugs (including methylphenidate)
• • History or current diagnosis of dementia
• • Patients with mood congruent or mood incongruent psychotic features
• • Current use of other psychotropic drugs
• • Clinical or laboratory evidence of hypothyroidism
• • Patients with a lifetime history of electroconvulsive therapy
• • Failure to meet standard magnetic resonance imaging safety requirements
• • Abnormal ECG and lab results
• • History of seizure disorder or currently on anticonvulsants