GWP42003 as adjunctive therapy to first line antipsychotics in schizophrenia and related psychotic disorders

• Conditions: Schizophrenia or related psychotic disorder; MedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-000212-22-GB
• Lead Sponsor: GW Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-30
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

-Participant is willing and able to give written informed consent for participation in the study and does not require involuntary treatment.
-Male or female participant(s) aged 18 to 65 years.
-Participant is able (in the investigator’s opinion) and willing to comply with all study requirements.
-Participant is diagnosed with schizophrenia or a related psychotic disorder (such as schizoaffective or schizophreniform disorder) as defined by the Diagnostic and Statistical Manual of Mental Disorders Version 4.
-Participant must have been treated for a minimum of four-weeks and be on a stable dose of their current AP medication.
-Participant must have shown the capacity to respond at least partially to first line AP medication in the opinion of the investigator.
-Participant must be able to remain stable on their dose of AP and concomitant medications for the duration of the study, in the opinion of the investigator.
-Participant is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
-Participant is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Products (IMPs).
-Participant has a PANSS Total score of < 60 at Visit 1.
-Participant presents with a current clinical picture and/or history that is consistent with:
?delirium or dementia
?acute drug induced psychosis
?bipolar disorder
-Participant is taking more the one AP medication during the study.
-Female participants of child bearing potential and male participants whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however a male condom should not be used in conjunction with a female condom).
-Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
-Participants who have received an IMP within 30 days prior to the screening visit.
-Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
-Following a physical examination, the participant has any abnormalities that, in the opinion of the investigator would prevent the participant from safe participation in the study.
-Unwilling to abstain from donation of blood during the study.
-Travel outside the country of residence planned during the study.
-Participants previously randomised into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified