Psilocibina - Neuroplasticità indotta nel trattamento del disturbo depressivo maggiore
The primary goal of this pilot study is to investigate whether psilocybin alters neuroplasticity in people with major depressive disorder. The primary hypothesis is that psilocybin will result in neuroplastic changes that parallel improvement in symptoms of depression.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
In this placebo-controlled, blinded study, individuals with depression will participate in 2 experimental sessions approximately 4 weeks apart during which they will receive two of the following three interventions: 1) placebo, 2) low dose psilocybin (0.1 mg/kg), and 3) medium dose psilocybin (0.3 mg/kg).
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Connecticut
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West Haven, Connecticut, Stati Uniti, 06516
- VA Connecticut Healthcare System, West Haven Campus
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosed with Major Depressive Disorder (MDD), single or recurrent episode, and currently experiencing a Major Depressive Episode (MDE)
- Failed to achieve a satisfactory clinical response to at least one adequate antidepressant trial during the current depressive episode
- Currently engaged in treatment with a mental health clinician
Exclusion Criteria:
- Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
- Axis I psychotic disorder in first degree relative
- Currently taking a conventional antidepressant medication
- Unstable medical or neurological conditions
- Significant cognitive disorders
- History of intolerance to drugs known to significantly alter perception e.g., psilocybin, LSD, salvinorin A, mescaline, etc.
- Pregnant, breastfeeding, lack of adequate birth control
- Urine toxicology positive to drugs of abuse on experimental test days
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Placebo/Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session. |
0.1 mg/kg psilocybin capsule microcrystalline cellulose capsule |
|
Sperimentale: Placebo/Medium Dose Psilocybin
Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session. |
microcrystalline cellulose capsule 0.3 mg/kg psilocybin capsule |
|
Sperimentale: Low Dose Psilocybin/Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session. |
0.1 mg/kg psilocybin capsule microcrystalline cellulose capsule |
|
Sperimentale: Medium Dose Psilocybin/Placebo
Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session. |
microcrystalline cellulose capsule 0.3 mg/kg psilocybin capsule |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)
Lasso di tempo: One day and two weeks after each experimental session
|
An auditory Long Term Potentiation (LTP) task will assess changes in neuroplasticity. For the EEG task, the outcome measures will include stimulus-evoked time x frequency analysis (e.g., spectral power) |
One day and two weeks after each experimental session
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes in verbal memory [ Time Frame: One day and two weeks after each experimental session ]
Lasso di tempo: One day and two weeks after each experimental session
|
This will be measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT), administered while EEG data is collected. The EEG outcomes will include time x frequency analysis (e.g., spectral power) during the learning and recognition phases of the task. |
One day and two weeks after each experimental session
|
|
Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D)
Lasso di tempo: Four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.
|
The GRID-Hamilton Depression Rating Scale is a clinician-administered rating scale designed to assess severity of depressive symptoms. It includes 17 items, nine of which are scored on 5-point scale, and eight of which are scored on a three-point scale. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. |
Four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.
|
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Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16)
Lasso di tempo: Four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session.
|
The QIDS-SR16 is a 16-item self-reported rating scale designed to assess severity of depressive symptoms. |
Four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Deepak D'Souza, MD, Yale University
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Inizio studio (Effettivo)
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Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
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Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2000022394
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