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

• Sponsor: Erich Seifritz (Other)
• Overall Status: Completed
• CT.gov ID: NCT04082806
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site Per Month: 2.7

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: GHB; Drug: Trazodone; Drug: Placebos	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 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.
• Actual Study Start Date: Aug 6, 2020
• Actual Primary Completion Date: Apr 6, 2022
• Actual Study Completion Date: Apr 6, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. slow wave sleep amount [1 night]

   slow wave sleep time (minutes) during the experimental night

2. performance in emotional memory consolidation tasks by Emotional Picture Memory Task (EPMT) [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) [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) [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). [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 [10 hours after solid drug administration]

   Results are measured in number of correct answers

7. homeostatic sleep pressure by N-back Task [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) [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) [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) [0minutes, 15minutes, 30minutes, 45minutes and 60minutes after awekening]

   Cortisol concetration in Saliva (nmol/l)

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatric University Hospital	Zürich	ZH	Switzerland	8032

Sponsors and Collaborators

• Erich Seifritz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Sep 9, 2019
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• 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: Depressive Disorder; Depression; Depressive Disorder, Major; Trazodone

Study Results

No Results Posted as of May 12, 2022