Differences in serotonin synthesis between patients with major depression and healthy controls, measured with [11C]5-HTP PET
- Conditions
- Affective disorderDepression10027946
- Registration Number
- NL-OMON39051
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
Patients
- Out-patients
- Age 18-55.
- Major depressive disorder, single or recurrent episode according to DSM IV.
- Severity: >22 IDS-SR
- No psychotic features
- No intention to commit suicide, or a history of a seroious suicide attempt
- No proven non-response to CBT during the current or a previous episode
- No current or recent (< 3 months) alcohol or substance use disorder (smoking is allowed).
- Declared somatically healthy after medical examination.
- No current or recent (<1 month) pharmacological treatment (antidepressant, antipsychotic, lithium, anticonvulsant, benzodiazepine)
- Understanding Dutch language and judged capable to participate
- Willing to cooperate and sign the informed consent form.;Healthy volunteers
- Matched for gender and age
- Age 18-55.
- No lifetime major psychiatric disorders (e.g. psychosis, mood disorder, anxiety disorder, somatoform disorder, eating disorder)
- No lifetime treatment with an antidepressant, antipsychotic, lithium or anticonvulsant
- No long-term treatment (>1 month) and no current (<1 month) with a benzodiazepine
- No current or recent (< 3 months) alcohol or substance abuse and no lifetime alcohol or substance dependence (smoking is allowed)
- Declared somatically healthy after medical examination.
- Willing to cooperate and sign the informed consent form.
Similar for patients and healthy controls
- Indication of medical/somatic illness that could interfere with study results or constitutes a risk factor when participating in the study and undergoing treatment.
- Cardiovascular abnormalities that may be a risk factor when participating in the study.
- Neurological damage or previous severe head injury
- Consumption of chocolate, caffeinated products or tabacco within 24 hours of the scan.
- Pregnancy or the intention to become pregnant during the estimated time course of the study.
- Radiation exposure (for diagnostic reasons) as a radiological worker or during medical trial in the previous year.
- Claustrophobia
- Presence of materials in the body that can be magnetized, like:
i. A pacemaker
ii. Metal fragments
iii. Shunts
iv. Artificial heart valves
v. Vascular clips
vi. Fixed hearing aid
vii. Tattoos containing metal
viii. Hair implants
ix. Artificial dentures
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameter is the constant accumulation Kacc or Patlak rate (similar<br /><br>parameters resembling serotonin synthesis rate) in the brains, along with the<br /><br>scores on the IDS-SR. In addition, the k3, resembling AADC activity, will be<br /><br>measured.<br /><br>The difference (IDS-SR, Kacc, k3 or Patlak rate) between patients and healthy<br /><br>volunteers is shown as absolute values**. In addition, the Patlak Kacc and the<br /><br>scores on the IDS-SR correlated. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are the ratio between tryptophan levels in plasma and<br /><br>other large amino acids and polymorphisms for several serotonin-related genes<br /><br>like the serotonin transporter, the 5-HT1A receptor, and tryptophan<br /><br>hydroxylase. In addition, the outcomes of the personality questionnaires are<br /><br>compared between the two groups and aspects like neuroticism and copings style<br /><br>are correlated to Kacc and Patlak rates. Also the outcome of the fMRI tasks and<br /><br>the MRS are related to Kacc and Patlak rates.</p><br>