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

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ClinicalTrials.gov Identifier: NCT04082806
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Erich Seifritz, Psychiatric University Hospital, Zurich

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: GHB Drug: Trazodone Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: healthy controls Drug: GHB
50 mg/kg GHB at one experimental night

Drug: Trazodone
1.5 mg/kg trazodone at one experimental night

Drug: Placebos
placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)

Experimental: Major Depressive Disorder Drug: GHB
50 mg/kg GHB at one experimental night

Drug: Trazodone
1.5 mg/kg trazodone at one experimental night

Drug: Placebos
placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Erich Seifritz, Head of department for psychiatry, psychotherapy and psychosomatic, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier: NCT04082806    
Other Study ID Numbers: Mem-GHB-TRA-Study
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents