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

NCT04082806 | Completed Phase 2 DMC

• 1 other identifier: Mem-GHB-TRA-Study
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (7)

• slow wave sleep amount

  slow wave sleep time (minutes) during the experimental night

  1 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)

  10 hours after encoding

• 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

• 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

• 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

• homeostatic sleep pressure by Psychomotor Vigilance Task

  Results are measured in number of correct answers

  10 hours after solid drug administration

• homeostatic sleep pressure by N-back Task

  Results are measured in number of correct answers

  10 hours after solid drug administration

Secondary Outcomes (4)

• Sleep quality assessed by Morgen Questionionnaire (MQ)

  at 8:00 a.m. after experimental night 1,2 and 3

• Sleep quality assessed by Karolinska Schläfrigkeitsskala (SKK)

  at 8:00 a.m. after experimental night 1,2 and 3

• Cortisol Saliva Response (CAR)

  0minutes, 15minutes, 30minutes, 45minutes and 60minutes after awekening

• Score on Positive and Negative Affect Schedule (PANAS)

  8 hours after solid drug administration

Study Arms (2)

healthy controls

EXPERIMENTAL

Drug: GHB; Drug: Trazodone; Drug: Placebos

Major Depressive Disorder

EXPERIMENTAL

Drug: GHB; Drug: Trazodone; Drug: Placebos

Interventions

GHB DRUG

50 mg/kg GHB at one experimental night

Major Depressive Disorder; healthy controls

Trazodone DRUG

1.5 mg/kg trazodone at one experimental night

Major Depressive Disorder; healthy controls

Placebos DRUG

placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)

Major Depressive Disorder; healthy controls

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Erich Seifritz: lead

Study Sites (1)

Psychiatric University Hospital

Zurich, Canton of Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of department for psychiatry, psychotherapy and psychosomatic

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 9, 2019
• Study Start: August 6, 2020
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

CH (1)