Cannabinoids in Bipolar Affective Disorder
Paraules clau
Resum
Descripció
This study will be a within-subject, random order, double-blind cross-over study with standard clinical and neuropsychological ratings. Duration is 13 weeks per subject. Clinical assessments including mood ratings will be performed weekly. Instructions and practice on the use of the spray will be given under supervision during a 2-week run-in period before baseline. Patients can control the dosage of cannabinoids according to their symptoms by administering up to a maximum of 48 pump-controlled sprays per day. Patients will be asked to abstain from using cannabis (other than the study drug) during the study. Patients will be treated for 4 weeks with either the sublingual THC:CBD spray or placebo spray. This will be followed by a 2-week washout period before another 4 weeks of treatment with whichever study medication was not initially used. Neurocognitive testing will be performed 3 times during the study. A mood diary will be completed daily by each patient at home.
Dates
| Darrera verificació: | 08/31/2014 |
| Primer enviat: | 11/06/2006 |
| Inscripció estimada enviada: | 11/07/2006 |
| Publicat per primera vegada: | 11/08/2006 |
| Última actualització enviada: | 09/15/2014 |
| Publicació de l'última actualització: | 09/17/2014 |
| Data d'inici de l'estudi real: | 10/31/2006 |
| Data estimada de finalització primària: | 11/30/2013 |
| Data estimada de finalització de l’estudi: | 11/30/2013 |
Condició o malaltia
Intervenció / tractament
Drug: Crossover
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Crossover | Drug: Crossover Randomized crossover study of 2 weeks of active study medication (maximum daily dosage of 60 mg) vs. 2 weeks of matching placebo. |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 19 Years Per a 19 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: - Outpatients between the 19-60 years of age with a diagnosis of bipolar disorder. - Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study. - Subjects must be on stable medication (4 weeks minimum) for their bipolar illness (symptomatic despite current treatment), must be able to provide written informed consent, must adequately understand written and verbal English. Exclusion Criteria: - Those not meeting the inclusion criteria and those not able to give informed consent. - Women who are currently pregnant or nursing. - Those at immediate risk of harming self or others; - those who have a clinically significant medical illness or other significant psychiatric illness; - currently abusing alcohol or drugs; - currently being treated with an investigational medication or medication that is contraindicated with cannabinoids; - have a known allergy to cannabis-based products. |
Resultat
Mesures de resultats primaris
1. To determine whether a standardized plant extract of cannabis containing a 1:1 ratio of THC & CBD can alleviate bipolar mood symptoms unresponsive to standard treatment. To be measured weekly over 13 weeks. [13 weeks]
Mesures de resultats secundaris
1. To determine the effects on cognition. [undefined]
2. To be measured at baseline and at the end of each treatment phase. [undefined]
