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

E

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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