Major Depressive DisorderPhase 2NCT04082806
Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
A Phase 2 study testing GHB and Trazodone in people with Major Depressive Disorder, run by Erich Seifritz at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- GHB and Trazodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Aug 2020to 6 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric University Hospital
Zurich, Canton of Zurich, 8032
About this study
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
- Being tested
- GHB, Trazodone, Placebos
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GHBDrug
50 mg/kg GHB at one experimental night
TrazodoneDrug
1.5 mg/kg trazodone at one experimental night
PlacebosDrug
placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Experimental | Not described Receives: Drug: GHB; Drug: Trazodone; Drug: Placebos |
| Major Depressive Disorder | Experimental | Not described Receives: Drug: GHB; Drug: Trazodone; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
slow wave sleep amount
slow wave sleep time (minutes) during the experimental night
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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)
Measured: 9 hours after solid drug administration
homeostatic sleep pressure by Psychomotor Vigilance Task
Results are measured in number of correct answers
Measured: 10 hours after solid drug administration
homeostatic sleep pressure by N-back Task
Results are measured in number of correct answers
Measured: 10 hours after solid drug administration
Secondary outcomes (4)
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.
Measured: at 8:00 a.m. after experimental night 1,2 and 3
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.
Measured: at 8:00 a.m. after experimental night 1,2 and 3
Cortisol Saliva Response (CAR)
Cortisol concetration in Saliva (nmol/l)
Measured: 0minutes, 15minutes, 30minutes, 45minutes and 60minutes after awekening
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)
Measured: 8 hours after solid drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start6 Aug 2020
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erich Seifritz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erich Seifritz, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082806
- Sponsor's protocol ID
- Mem-GHB-TRA-Study
- Status last verified
- May 2022
- First submitted
- 28 Aug 2019
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
- ClinicalTrials.gov ID
- NCT04082806
- Acronym / sponsor ID
- Mem-GHB-TRA-Study
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Erich SeifritzUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy controls | Experimental | Drug: GHB, Drug: Trazodone, Drug: Placebos |
| Major Depressive Disorder | Experimental | Drug: GHB, Drug: Trazodone, Drug: Placebos |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GHB50 mg/kg GHB at one experimental night | Drug | Major Depressive Disorder, healthy controls |
| Trazodone1.5 mg/kg trazodone at one experimental night | Drug | Major Depressive Disorder, healthy controls |
| Placebosplacebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon) | Drug | Major Depressive Disorder, healthy controls |
Primary outcome
slow wave sleep amount
Time frame: 1 night
slow wave sleep time (minutes) during the experimental night
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)
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
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).
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)
homeostatic sleep pressure by Psychomotor Vigilance Task
Time frame: 10 hours after solid drug administration
Results are measured in number of correct answers
homeostatic sleep pressure by N-back Task
Time frame: 10 hours after solid drug administration
Results are measured in number of correct answers
4 secondary outcomes
Sleep quality assessed by Morgen Questionionnaire (MQ)
Time frame: at 8:00 a.m. after experimental night 1,2 and 3
Sleep quality assessed by Karolinska Schläfrigkeitsskala (SKK)
Time frame: at 8:00 a.m. after experimental night 1,2 and 3
Cortisol Saliva Response (CAR)
Time frame: 0minutes, 15minutes, 30minutes, 45minutes and 60minutes after awekening
Score on Positive and Negative Affect Schedule (PANAS)
Time frame: 8 hours after solid drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GHB and Trazodone in people with Major Depressive Disorder, run by Erich Seifritz at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
slow wave sleep amount (time frame: 1 night). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.