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

GHB

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).

Intervention / Treatment

  • GHB (DRUG)
    50 mg/kg GHB at one experimental night
  • Trazodone (DRUG)
    1.5 mg/kg trazodone at one experimental night
  • Placebos (DRUG)
    placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)

Condition or Disease

  • Major Depressive Disorder

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 20 Years to 65 Years
    Enrollment: 54 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 06, 2020 ACTUAL
    Primary Completion: Apr 06, 2022 ACTUAL
    Completion Date: Apr 06, 2022 ACTUAL
    Study First Posted: Sep 09, 2019 ACTUAL
    Last Updated: May 11, 2022

    Sponsors / Collaborators

    Lead Sponsor: Erich Seifritz
    Responsible Party: Erich Seifritz

    Location

    Zürich, Switzerland

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 20
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • slow wave sleep time (minutes) during the experimental night

    • results in EPMT are measured as number of recognized pictures (1-150)

    • results in FSTT are measured as number of correct sequences typed in 30seconds

    • Results in PAWL are expressed as number of correct word pairs recalled (1-40).

    • Assessed in serum samples collected by venipuncture using a butterfly needle. Unit of measure as blood concentration (ng/l or mg/ml)

    • Results are measured in number of correct answers

    • Results are measured in number of correct answers

    Secondary Outcomes

    • 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.

    • Subjects will report their subjective sleep pressure in a 1-10 points scale. Low values mean low sleep pressure and better therapy response.

    • Cortisol concetration in Saliva (nmol/l)

    • 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)

    More Details

    NCT Number: NCT04082806
    Other IDs: Mem-GHB-TRA-Study
    Study URL: https://clinicaltrials.gov/study/NCT04082806
    Last updated: Sep 29, 2023