Back to resultsMemory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
GHB
Trazodone
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility 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
Sites / Locations
- Psychiatric University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
healthy controls
Major Depressive Disorder
Arm Description
Outcomes
Primary Outcome Measures
slow wave sleep amount
slow wave sleep time (minutes) during the experimental night
performance in emotional memory consolidation tasks by Emotional Picture Memory Task (EPMT)
results in EPMT are measured as number of recognized pictures (1-150)
performance in procedural memory consolidation tasks by Finger Sequence-Tapping Task (FSTT)
results in FSTT are measured as number of correct sequences typed in 30seconds
performance in declarative memory consolidation tasks by Paired Word List Task (PAWL)
Results in PAWL are expressed as number of correct word pairs recalled (1-40).
Blood levels of Brain Derived Neurotrophic Factor (BDNF).
Assessed in serum samples collected by venipuncture using a butterfly needle. Unit of measure as blood concentration (ng/l or mg/ml)
homeostatic sleep pressure by Psychomotor Vigilance Task
Results are measured in number of correct answers
homeostatic sleep pressure by N-back Task
Results are measured in number of correct answers
Secondary Outcome Measures
Sleep quality assessed by Morgen Questionionnaire (MQ)
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.
Sleep quality assessed by Karolinska Schläfrigkeitsskala (SKK)
Subjects will report their subjective sleep pressure in a 1-10 points scale. Low values mean low sleep pressure and better therapy response.
Cortisol Saliva Response (CAR)
Cortisol concetration in Saliva (nmol/l)
Score on Positive and Negative Affect Schedule (PANAS)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04082806
Brief Title
Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
Official Title
Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
April 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erich Seifritz
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy controls
Arm Type
Experimental
Arm Title
Major Depressive Disorder
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GHB
Intervention Description
50 mg/kg GHB at one experimental night
Intervention Type
Drug
Intervention Name(s)
Trazodone
Intervention Description
1.5 mg/kg trazodone at one experimental night
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)
Primary Outcome Measure Information:
Title
slow wave sleep amount
Description
slow wave sleep time (minutes) during the experimental night
Time Frame
1 night
Title
performance in emotional memory consolidation tasks by Emotional Picture Memory Task (EPMT)
Description
results in EPMT are measured as number of recognized pictures (1-150)
Time Frame
10 hours after encoding
Title
performance in procedural memory consolidation tasks by Finger Sequence-Tapping Task (FSTT)
Description
results in FSTT are measured as number of correct sequences typed in 30seconds
Time Frame
10 hours after encoding
Title
performance in declarative memory consolidation tasks by Paired Word List Task (PAWL)
Description
Results in PAWL are expressed as number of correct word pairs recalled (1-40).
Time Frame
10 hours after encoding
Title
Blood levels of Brain Derived Neurotrophic Factor (BDNF).
Description
Assessed in serum samples collected by venipuncture using a butterfly needle. Unit of measure as blood concentration (ng/l or mg/ml)
Time Frame
9 hours after solid drug administration
Title
homeostatic sleep pressure by Psychomotor Vigilance Task
Description
Results are measured in number of correct answers
Time Frame
10 hours after solid drug administration
Title
homeostatic sleep pressure by N-back Task
Description
Results are measured in number of correct answers
Time Frame
10 hours after solid drug administration
Secondary Outcome Measure Information:
Title
Sleep quality assessed by Morgen Questionionnaire (MQ)
Description
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.
Time Frame
at 8:00 a.m. after experimental night 1,2 and 3
Title
Sleep quality assessed by Karolinska Schläfrigkeitsskala (SKK)
Description
Subjects will report their subjective sleep pressure in a 1-10 points scale. Low values mean low sleep pressure and better therapy response.
Time Frame
at 8:00 a.m. after experimental night 1,2 and 3
Title
Cortisol Saliva Response (CAR)
Description
Cortisol concetration in Saliva (nmol/l)
Time Frame
0minutes, 15minutes, 30minutes, 45minutes and 60minutes after awekening
Title
Score on Positive and Negative Affect Schedule (PANAS)
Description
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)
Time Frame
8 hours after solid drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Psychiatric University Hospital
City
Zürich
State/Province
ZH
ZIP/Postal Code
8032
Country
Switzerland
12. IPD Sharing Statement
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Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
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