F33.2 F33.3
Conditions
Interventions
Group 1: sleep deprivation one night, after a break of 7 days electroconvulsive therapy starts for a course of 6 weeks, 2 times weekly
treatment in patient with major depression
Group 2: healthy controls without intervention
Sponsors
Universitätsklinik Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: a) written informed consent b) age 18 to 80 years c) patients: diagnosis of major depression according to ICD10 criteria AND refractory to at least two preceding evidence-based therapies, scheduled for SD and ECT d) cerebral MRI without structural changes possibly responsible for an affective disorder
Exclusion criteria
Exclusion criteria: e) pregnancy (excluded by pregnancy test in fertile women) and lactation f) comorbidity of another psychiatric disease (axis I disorder or substance abuse within last 6 months in patients resp. ever in controls) g) intake of drugs or substances inferring with DAT binding (e.g. mazindol, bupropione, radafaxine, amphetamine, methamphetamine, methylphenidate, cocaine, etc.) h) conditions that may preclude proper SPECT acquisition (e.g., severe claustrophobia, back pain, etc.) i) previous participation in nuclear medicine trials j) participation in medical trails within the last 6 months k) symptomatic affective disorder (e.g, due to a structural brain lesion on MRI) l) severe neurological disease, in particular those affecting nigrostriatal integrity (e.g., dementia, neurodegenerative Parkinson syndrome, restless legs syndrome, epilepsy, cerebrovascular disease) m) any malignant disease with possible impact on life expectancy n) severe cardiovascular disease e.g. Angina, chronic heart failure, arrhythmia) o) any severe internal disease with possible impact on life expectancy (e.g., CAD, uncontrolled hypertension, liver or kidney disease, etc.) p) known allergic reaction on perchlorate, relevant thyroid disease (e.g., thyroid cancer; preoperative need to block thyroid with iodine), relevant abnormal blood counts, earlier blood count changes due to perchlorate. q) acute suicidal tendencies r)difficulties to give informend consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of striatal DAT availability in patients with major depression at baseline, after one night of total SD and after 6 weeks of ECT assessed with [123I]FP-CIT SPECT | — |
Secondary
| Measure | Time frame |
|---|---|
| - comparison of DAT availability in major depression with DAT availability of healthy controls at baseline, after one night of total SD and after 6 weeks of ECT with [123I]FP-CIT-SPECT - correlation of DAT availability in major depression and healthy controls with DAT availability of lymphcytes at baseline, after one night of total SD and after 6 weeks of ECTby semiquantitative PCR from blood samples - comparison of clinical parameters. psychiatric examination (especially affectivity and cognitive function) in patients at baseline, after one night of total SD and after 6 weeks of ECTby standardized clincial tests (HMD; BDI; congitive test battery). - correlation of clinical parameters with striatal and lymphocatic DATavailability in major depression at baseline, after one night of total SD and after 6 weeks of ECT -correlation of biomarkers (polymorphisms of DAT-gen, of adenosindesaminase-gen by PCR from blood samples, saliva cortisol) with striatal und lymphcytic DAT-availability -correlation of clinical parameters with above mentioned biomarkers. | — |
Countries
Germany
Contacts
Public ContactSabine Hellwig
Universitätsklinikum Freiburg
Outcome results
None listed