Cortical GABA Concentrations in Insomnia
The Association of Cortical GABA Concentrations in Subjects With Primary Insomnia and Depression in Partial Remission With Residual Insomnia
Studieoversikt
Status
Status
Forhold
Forhold
Detaljert beskrivelse
Studietype
Studietype
Registrering (Faktiske)
Registrering
Kontakter og plasseringer
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forente stater, 06519
- Yale Depression Research Program
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Patient Sample.
- Healthy subjects without insomnia (Group A) (n=10)
- Subjects with primary insomnia (Group B) (n=20)
- Subjects with a history of major depressive disorder and currently in partial remission but with residual insomnia (Group C) (n=20)
Inclusion Criteria for Primary Insomnia Subjects:
- Males or females between the ages of 25 and 55 years
- Clinical diagnosis of primary insomnia meeting DSM-IV criteria.
- Current insomnia ratings (current Sleep Onset Latency SOL > 30 minutes, Insomnia Severity Index (ISI) > 14, total sleep time (TST) < 6.5 hrs/night).
- No lifetime history of psychopathology other than primary insomnia.
- No sleep disorders previously identified as related to other conditions including sleep disordered breathing, restless leg syndrome, periodic limb movement disorder, chronic pain, gastro-esophageal reflux disease, sleep paralysis, nocturnal seizures, nocturia, enuresis; also narcolepsy and REM behavior disorders (assessed by clinical interview and Harvard Center and Cognition Habitual Sleep Survey).
Inclusion Criteria for Depressed Subjects:
- Males or females between the ages of 25 and 55 years
- Clinical diagnosis of major depression meeting DSM-IV criteria in partial remission (HDRS-8-17), confirmed after semi-structured interview with the SCID and HDRS.
- On monotherapy with a single SSRI medication for a period of at least 6-weeks.
- Remaining symptoms of insomnia (current Sleep Onset Latency (SOL) > 30 minutes, Insomnia Severity Index (ISI) > 14, TST < 6.5 hrs/night).
- Participation is judged clinically appropriate by treatment team.
- No sleep disorders previously identified as related to other conditions including sleep disordered breathing, restless leg syndrome, periodic limb movement disorder, chronic pain, gastro-esophageal reflux disease, sleep paralysis, nocturnal seizures, nocturia, enuresis; also narcolepsy and REM behavior disorders.
Inclusion Criteria for Healthy Control Subjects:
- Males or females between the ages of 25 and 55 years
- No lifetime history of psychopathology or insomnia (current SOL < 30mins, ISI < 4, TST > 6.5 hrs)
- At low risk for depression (e.g., no first degree relative with child onset, recurrent, psychotic or bipolar depression)
Exclusion Criteria for all Subjects:
- History of serious medical or neurological illness
- Signs of major medical or neurological illness on examination or as a result of laboratory studies
- History of psychoactive substance and/or alcohol dependence or abuse in past 6-months.
- Current use of any psychoactive medication or substance (with the exception of caffeine, as noted below, and the use of an SSRI in the depressed group), during the two weeks prior to the initial scan.
- More than the caffeine-equivalent of 3 cups of coffee per day, or any regular (i.e., more than 1x/2 weeks) use of caffeine after 7pm.
- Use of benzodiazepines or olanzapine in past 3-months.
- Pregnant or nursing
- Any implanted metal devise or metal fragments
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Tverrsnitt
Antall grupper / kohorter
Kohorter og intervensjoner
Gruppe / KohortGruppe / Kohort |
|---|
|
1 Primary Insomnia
Individuals with insomnia not related to another identified cause.
|
|
3 Healthy comparison subjects
Healthy subjects with no history of insomnia
|
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Cortical GABA levels as measured by proton MRS
Tidsramme: baseline
|
baseline
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ambulatory polysomnography
Tidsramme: baseline
|
baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Samarbeidspartnere
Samarbeidspartnere
Etterforskere
Etterforskere
- Hovedetterforsker: Gerard Sanacora, M.D.,Ph.D., Yale University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiestart
Primær fullføring (Faktiske)
Primær fullføring
Studiet fullført (Faktiske)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
Andre studie-ID-numre
- 0707002830
- ESRC 057
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .