Major Depressive Disorder
Conditions
Brief summary
30 healthy adults and 30 patients with major depressive disorder, will take part in three single-application pharmacological interventions (GHB vs. Trazodone vs. placebo p.o.) to test potential effects of these drugs on nocturnal memory consolidation. All participants will be assessed with mood state questionnaires, tests of emotional, procedural and declarative memory consolidation, polysomnography, EEG and neuroinflammatory biomarkers. At experimental nights, learning tasks are performed prior to sleep. The next morning, recalling tasks are performed. Each subject will pass through 5 study nights (1 screening, 1 adaptation and 3 experimental nights).
Interventions
DRUGGHB
50 mg/kg GHB at one experimental night
DRUGTrazodone
1.5 mg/kg trazodone at one experimental night
DRUGPlacebos
placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)
Sponsors
Erich Seifritz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Arm 1 (healthy controls): * Healthy participants, * Non-smoker, * Age 20-65 years Arm 2 (patients with depression): * Diagnosis of major depression (DSM-V), * Selective Serotonin-Reuptake-Inhibitor (SSRI) or Selective Serotonin-Noradrenalin-Reuptake-Inhibitor (SSNRI) medication, * Age 20-65 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| homeostatic sleep pressure by N-back Task | 10 hours after solid drug administration | Results are measured in number of correct answers |
| performance in procedural memory consolidation tasks by Finger Sequence-Tapping Task (FSTT) | 10 hours after encoding | results in FSTT are measured as number of correct sequences typed in 30seconds |
| performance in declarative memory consolidation tasks by Paired Word List Task (PAWL) | 10 hours after encoding | Results in PAWL are expressed as number of correct word pairs recalled (1-40). |
| Blood levels of Brain Derived Neurotrophic Factor (BDNF). | 9 hours after solid drug administration | Assessed in serum samples collected by venipuncture using a butterfly needle. Unit of measure as blood concentration (ng/l or mg/ml) |
| homeostatic sleep pressure by Psychomotor Vigilance Task | 10 hours after solid drug administration | Results are measured in number of correct answers |
| slow wave sleep amount | 1 night | slow wave sleep time (minutes) during the experimental night |
| performance in emotional memory consolidation tasks by Emotional Picture Memory Task (EPMT) | 10 hours after encoding | results in EPMT are measured as number of recognized pictures (1-150) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality assessed by Karolinska Schläfrigkeitsskala (SKK) | at 8:00 a.m. after experimental night 1,2 and 3 | Subjects will report their subjective sleep pressure in a 1-10 points scale. Low values mean low sleep pressure and better therapy response. |
| Cortisol Saliva Response (CAR) | 0minutes, 15minutes, 30minutes, 45minutes and 60minutes after awekening | Cortisol concetration in Saliva (nmol/l) |
| Score on Positive and Negative Affect Schedule (PANAS) | 8 hours after solid drug administration | self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much) |
| Sleep quality assessed by Morgen Questionionnaire (MQ) | at 8:00 a.m. after experimental night 1,2 and 3 | structured interview about sleep quality on the previous night. Subjektive sleep time will be assessed in minutes (0-480 minutes). Long sleep time will be a good outcome. Interview time of 5minutes. |
Countries
Switzerland
Outcome results
None listed