Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.

Erich Seifritz

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Placebos; Drug: Trazodone; Drug: GHB

Study type: Interventional

Funder types: Other

Identifiers

NCT04082806

Mem-GHB-TRA-Study

Details and patient eligibility

About

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).

Enrollment: 54 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

healthy controls

Experimental group

Treatment:

Drug: Placebos

Drug: Trazodone

Drug: GHB

Major Depressive Disorder

Experimental group

Treatment:

Drug: Placebos

Drug: Trazodone

Drug: GHB