- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02048995
Neural and Visual Responses to Light in Bipolar Disorder: A Novel Putative Biomarker (LightEyeBD)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The study goal is to understand how the response to light therapy relates to changes in vision, brain function and improvement in bipolar symptoms. The aims are to investigate mood levels plus the eye and brain responses to visual contrast stimuli in healthy comparators (HC) and bipolar depressed patients.
Study Design and Methods. Overview. The investigators plan to enroll 18-50 year old adults with BD Type I or II and a current episode of major depression on stable-dosed antimanic drugs, and age and sex-matched HC - without mental disorders. Depressed patients with BD will be assigned randomly to receive active light therapy vs inactive comparator for 6 weeks. The investigators will examine responses to contrast stimuli from measures of visual evoked potentials and electro-retinography in HC and depressed bipolar patients before and after 6-weeks of daily midday light therapy. The investigators will assess repeated measures of mood symptom levels, attention and circadian rhythms.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- Western Psychiatric Institute and Clinic
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Ages 18-50 years.
- DSM-IV BD Type I or II, current major depressive episode
- Stable-dosed antidepressant drug for 4 weeks or more only with concurrent antimanic drug.
- Controlled thyroid disease.
- Subjects with preexisting eye diseases will be included specific exceptions are described in the Exclusion Criteria.
- Able to provide informed consent.
- Stable minimum dose of antimanic drug for 4weeks or more.
- Stable unchanged psychotherapy for 16 weeks or more.
- Permitted drugs for sleep at low doses.
Exclusion Criteria:
- Certain specific eye diseases (retinal disease, untreated cataracts or macular degeneration)
- Photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
- Acute psychosis (DSM-IV Criteria)
- Rapid cycling in the past 1 year
- Alcohol or substance abuse or dependence in the past 6 months.
- Current symptoms of hypomania or mania i.e. ManiaRatingScale=5
- Recent history of a suicide attempt (3 months) or active suicidal ideation (SIGH-ADS item H11=2 or more)
- Treatment with propranolol (Inderal), exogenous melatonin, chronic NSAIDS.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Bipolar Depressed
Bipolar Depressed - are participants with Bipolar Disorder Type I or II and a current episode of major depression which is confirmed on the SCID interview
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Healthy Comparator
Healthy Comparator - are participants without mental disorders, alcohol or substance disorders confirmed by the SCID-interview
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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visual evoked potentials (VEP) waveforms (mean amplitudes or latencies)
Lasso di tempo: Week 0 and Week 6
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Visual Evoked Potential (VEP).
This is a test which is used to assess visual cortical responses.
The VEP recordings will be assessed at different contrast levels (80%, 16% and 7%) for the patient groups (BD vs HC).
To assess the change in visual cortical responses, we will compare differences in the VEP responses between Weeks 0 and 6 between the groups.
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Week 0 and Week 6
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Electroretinography (ERG) waveforms (mean amplitudes or latencies)
Lasso di tempo: Week 0 and Week 6
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Electroretinogram (ERG).
This is a test which is used to assess electrical responses of the retina.
The ERG recordings will be assessed at different contrast levels (80%, 16% and 7%) for the patient groups (BD vs HC).
To assess the change in retinal responses, we will compare differences in ERG responses between Weeks 0 and 6 between the groups.
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Week 0 and Week 6
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Dorothy Sit, M.D., University of Pittsburgh
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Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PRO14010387
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