Clinical TrialDepressive DisordersKetamineRecruiting

Imaging SV2A in Mood Disorders

correlate of synaptic density, and to determine whether ketamine administration will reverse the synaptic loss in vivo in human subjects

Target Enrollment
130 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

This non-randomised, parallel basic-science study compares SV2A availability across individuals with MDD, PTSD, bipolar disorder and healthy controls using PET (APP311/SDM-8/SynVesT-1).

A subset of participants undergo ketamine administration between scans to test whether ketamine increases SV2A density; imaging is combined with cognitive testing and physiological monitoring.

Outcomes include regional SV2A availability pre- and post-ketamine, correlations with antidepressant response, and examination of group and gender differences.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Single PET

inactive

Single PET scan on HRRT/HR+; vital signs and venous/arterial lines as required.

Ketamine PET

experimental

Baseline PET scan followed by low-dose ketamine and subsequent PET scan(s); bipolar subjects excluded from ketamine arms.

Interventions

  • Ketamine
    via IV• single dose• 1 doses total

    Low-dose ketamine administered after baseline scan; used to assess changes in SV2A

Treatment PET

inactive

PET scans for subjects undergoing clinical ketamine treatment (baseline and post-treatment scans); bipolar subjects not included in ketamine arms.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • General inclusion criteria:
  • 1. Subjects will be 18-70 years old.
  • 2. English speaking.
  • 3. No other DSM-5 diagnosis present, besides required as below.
  • Depressed subjects:
  • 1. Meet DSM-5 diagnostic criteria for Major Depressive Disorder and for a current depressive episode.
  • 2. Treatment- or non-treatment-seeking who understand this study is for research purposes only.
  • Healthy controls:
  • 1. No current or history of any DSM-5 diagnosis.
  • PTSD subjects:
  • 1. Current Post Traumatic Stress Disorder.
  • Bipolar subjects:
  • 1. Meet DSM-5 diagnostic criteria for bipolar disorder.
  • Subjects undergoing ketamine treatment:
  • 1. Meet DSM-5 criteria for MDD/current depressive episode and are undergoing ketamine treatment.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Significant medical illness contraindicating participation.
  • 2. Lifetime history of neurologic abnormality including seizure disorder, cerebrovascular/neoplastic lesion, neurodegenerative disorder, or significant head trauma with post-traumatic amnesia >24 hours.
  • 3. Full scale IQ <70.
  • 4. Contraindication to MRI (e.g., claustrophobia, ferromagnetic object, orthodontic braces).
  • 5. Pregnancy or breastfeeding.
  • 6. Met DSM-5 criteria for mild SUD (except nicotine and marijuana) within past 6 months or moderate–severe SUD within past year.
  • 7. Claustrophobia.
  • 8. Current psychosis, active suicidal or homicidal ideation.
  • 9. Positive urine toxicology screen (except marijuana).
  • 10. Contraindications to PET (e.g., past/current cancer, poor venous access).
  • 11. Prior research radiation exposure within past year placing subject over FDA annual limits.
  • 12. Occupational radiation exposure within one year that precludes participation.
  • 13. Blood pressure >130/80 (for ketamine challenge); BP >140/90 (non-ketamine groups).
  • 14. Arterial line exclusions: bleeding disorder or anticoagulant use.
  • 15. Arterial line exclusion: blood donation within eight weeks of study start.
  • 16. Current diagnosis of MDD or PTSD with psychotic features.
  • 17. Hematocrit <35 mg/dl or hemoglobin <10 mg/dl.
  • 18. Weight under 110 lbs for certain blood-draw portions of the study.

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment130 participants
  • Timeline
    Start: 2016-04-01
    End: 2024-03-01
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

PET Center — New Haven, Connecticut, United States

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