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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082806
• Other study ID #: Mem-GHB-TRA-Study
• Status: Completed
• Phase: Phase 2
• Start date: August 6, 2020
• Est. completion date: April 6, 2022

Study information

• Verified date: May 2022
• Source: Psychiatric University Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Switzerland	Psychiatric University Hospital	Zürich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Erich Seifritz

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	slow wave sleep amount	slow wave sleep time (minutes) during the experimental night	1 night
Primary	performance in emotional memory consolidation tasks by Emotional Picture Memory Task (EPMT)	results in EPMT are measured as number of recognized pictures (1-150)	10 hours after encoding
Primary	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	10 hours after encoding
Primary	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).	10 hours after encoding
Primary	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)	9 hours after solid drug administration
Primary	homeostatic sleep pressure by Psychomotor Vigilance Task	Results are measured in number of correct answers	10 hours after solid drug administration
Primary	homeostatic sleep pressure by N-back Task	Results are measured in number of correct answers	10 hours after solid drug administration
Secondary	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.	at 8:00 a.m. after experimental night 1,2 and 3
Secondary	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.	at 8:00 a.m. after experimental night 1,2 and 3
Secondary	Cortisol Saliva Response (CAR)	Cortisol concetration in Saliva (nmol/l)	0minutes, 15minutes, 30minutes, 45minutes and 60minutes after awekening
Secondary	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)	8 hours after solid drug administration