- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00765752
Cortical GABA Concentrations in Insomnia
18. januar 2013 oppdatert av: Gerard Sanacora, Yale University
The Association of Cortical GABA Concentrations in Subjects With Primary Insomnia and Depression in Partial Remission With Residual Insomnia
Disturbances in the amino acid neurotransmitter (AANt), gamma-amino butyric acid (GABA) function are hypothesized to contribute to the neurobiology of Major Depressive Disorder (MDD) and insomnia.
The principal objective of this project is to use magnetic resonance spectroscopy (MRS) to provide the first in vivo characterization of cortical GABA levels in individuals with primary insomnia, and to determine whether subjects with MDD, achieving a partial response with selective serotonin reuptake inhibitor treatment but still experiencing significant residual symptoms including insomnia, have altered levels of this neurotransmitter.
The investigators are also exploring the correlation between cortical AANt levels and abnormalities in sleep parameters in primary insomnia and as a residual symptom of major depression.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Three groups of subjects (MDD with partial remission and residual insomnia, primary insomnia, and healthy) will participate in the study.
All subjects will complete a telephone screening, and if appropriate a complete face-to-face evaluation, to determine their eligibility for the study.
All subjects meeting eligibility criteria for the study will complete a baseline MRS session to evaluate differences in GABA concentrations between the three groups.
Studietype
Observasjonsmessig
Registrering (Faktiske)
23
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Connecticut
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New Haven, Connecticut, Forente stater, 06519
- Yale Depression Research Program
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Community sample
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
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1 Primary Insomnia
Individuals with insomnia not related to another identified cause.
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3 Healthy comparison subjects
Healthy subjects with no history of insomnia
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cortical GABA levels as measured by proton MRS
Tidsramme: baseline
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baseline
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Ambulatory polysomnography
Tidsramme: baseline
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baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Gerard Sanacora, M.D.,Ph.D., Yale University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2007
Primær fullføring (Faktiske)
1. juni 2011
Studiet fullført (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først innsendt
1. oktober 2008
Først innsendt som oppfylte QC-kriteriene
2. oktober 2008
Først lagt ut (Anslag)
3. oktober 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. januar 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. januar 2013
Sist bekreftet
1. januar 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0707002830
- ESRC 057
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