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OpenTrials
Completed

NCT Number: NCT04082806

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

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).

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Psychiatric University Hospital

Zurich, Canton of Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. slow wave sleep amount

    Time frame: 1 night

    slow wave sleep time (minutes) during the experimental night

  2. performance in emotional memory consolidation tasks by Emotional Picture Memory Task (EPMT)

    Time frame: 10 hours after encoding

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

  3. performance in procedural memory consolidation tasks by Finger Sequence-Tapping Task (FSTT)

    Time frame: 10 hours after encoding

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

  4. performance in declarative memory consolidation tasks by Paired Word List Task (PAWL)

    Time frame: 10 hours after encoding

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

  5. Blood levels of Brain Derived Neurotrophic Factor (BDNF).

    Time frame: 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)

  6. homeostatic sleep pressure by Psychomotor Vigilance Task

    Time frame: 10 hours after solid drug administration

    Results are measured in number of correct answers

  7. homeostatic sleep pressure by N-back Task

    Time frame: 10 hours after solid drug administration

    Results are measured in number of correct answers

Secondary outcomes

  1. Sleep quality assessed by Morgen Questionionnaire (MQ)

    Time frame: 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.

  2. Sleep quality assessed by Karolinska Schläfrigkeitsskala (SKK)

    Time frame: 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.

  3. Cortisol Saliva Response (CAR)

    Time frame: 0minutes, 15minutes, 30minutes, 45minutes and 60minutes after awekening

    Cortisol concetration in Saliva (nmol/l)

  4. Score on Positive and Negative Affect Schedule (PANAS)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Erich Seifritz

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2019
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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