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

NCT ID: NCT04082806

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-06
• Study Completion Date: 2022-04-06

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).

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

healthy controls

Group Type: EXPERIMENTAL

GHB

Intervention Type: DRUG

50 mg/kg GHB at one experimental night

Trazodone

Intervention Type: DRUG

1.5 mg/kg trazodone at one experimental night

Placebos

Intervention Type: DRUG

placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)

Major Depressive Disorder

Group Type: EXPERIMENTAL

GHB

Intervention Type: DRUG

50 mg/kg GHB at one experimental night

Trazodone

Intervention Type: DRUG

1.5 mg/kg trazodone at one experimental night

Placebos

Intervention Type: DRUG

placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)

Interventions

GHB

50 mg/kg GHB at one experimental night

Intervention Type: DRUG

Trazodone

1.5 mg/kg trazodone at one experimental night

Intervention Type: DRUG

Placebos

placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erich Seifritz

OTHER

Sponsor Role: lead

Responsible Party

Erich Seifritz

Head of department for psychiatry, psychotherapy and psychosomatic

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Psychiatric University Hospital

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

Mem-GHB-TRA-Study

Identifier Type: -

Identifier Source: org_study_id