Exploring how ketamine affects emotional responses in depression

Translational Study of the Neural Circuits Underlying the Negative Emotional Bias of Depressive Disorders and Their Response to Ketamine

This study is testing how ketamine affects the way people with depression respond to emotions by looking at their brain activity and pupil reactions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier St Anne (Academic / other)
• Locations: 1 site (Paris, Paris)
• Trial ID: NCT06630065 on ClinicalTrials.gov

What this trial studies

This study investigates the neural circuits involved in the negative emotional bias associated with depressive disorders and how these circuits respond to ketamine treatment. It utilizes fMRI and pupillometry to assess emotional responses to various stimuli in patients diagnosed with unipolar or bipolar depression. The research aims to understand the changes in emotional valence perception in depressed individuals, particularly focusing on the role of the amygdala. Participants will include both patients receiving esketamine and control subjects without depressive disorders.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a diagnosis of unipolar or bipolar depression and a MADRS score greater than 20 who are undergoing treatment with esketamine.

Not a fit: Patients with psychiatric comorbidities, such as schizophrenia, or those with contraindications to MRI or esketamine will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment of emotional biases in depression, potentially enhancing therapeutic outcomes for patients.

How similar studies have performed: While the specific approach of this study is novel, previous studies have shown promising results in understanding the neural mechanisms of depression and the effects of ketamine.

Eligibility criteria

Inclusion Criteria:

Patient inclusion criteria :

* Age over 18
* Patient hospitalized or consulting at GHU Paris Psychiatrie et Neurosciences
* Patient with EDC (unipolar or bipolar) diagnosed according to the DSM-5 CRITERIA
* With MADRS score \> 20
* For whom a course of esketamine has been decided by the psychiatrist of the patient
* Patient having given written informed consent
* Patient covered by a social security plan

Inclusion criteria for control subjects :

* Over 18 years old
* No EDC assessed by MADRS \< 8

Exclusion Criteria:

Patient non-inclusion criteria:

* Psychiatric comorbidities: schizophrenic disorder or schizoaffective disorder, history of recreational use of ketamine
* Protected adults, persons under legal protection
* Contraindications to MRI, including refusal to be informed of the discovery of a clinically significant abnormality on MRI
* Pregnant or breast-feeding women
* Usual contraindications to esketamine :

  * Neurological comorbidity: epilepsy, neurodegenerative disease, cerebrovascular disease with recent history (\< 3 months) of stroke or ischemic attack or transient ischemic attack
  * Cardiological co-morbidity: vascular aneurysm, ischemic heart disease with acute elements or stent within the previous 12 months, uncontrolled hypertension, heart failure, rhythm or conduction disorders on ECG
  * History of cirrhosis (or ALAT, ASAT or bilirubin greater than 2 N)
  * Severe chronic respiratory insufficiency

Exclusion criteria for control subjects:

* MADRS \<8
* Contraindications to MRI, including refusal to be informed of a clinically significant clinically significant abnormality on MRI

Where this trial is running

Paris, Paris

• - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences — Paris, Paris, France (Recruiting)

Study contacts

• Principal investigator: Chantal Henry, Pr — GHU Paris Psychiatry & Neurosciences
• Study coordinator: Chantal Henry, Pr

Conditions Depressive Disorder