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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Tim
Mantingh
Tim.mantingh@kcl.ac.uk
Prof
Allan
Young
allan.young@kcl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Mood [affective] disorders
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Major depressive disorder is a burdensome and costly health problem for patients, carers, societies and governments. Resistance to medical and psychological treatments is common and this group are much more likely to be socioeconomically inactive, suffer from comorbid physical health problems and to die by suicide. Despite this, treatment resistant depression is under-researched and no new breakthrough paradigms of treatment have been developed since the introduction of the selective serotonin antidepressants and cognitive behavioural therapy in the 1980s. Combinations of antidepressants and psychotherapy are more effective than either alone. The psychedelic drugs, including psilocybin, were used by psychiatrists prior to prohibition in 1970 for treatment resistant cases of depression, anxiety and addictions. Within a supportive therapeutic context they showed promise in this group, however evidence about safety and efficacy was inconclusive prior to prohibition. Since 2010 a resurgence of interest in this treatment paradigm has occurred. We have completed an uncontrolled, open-label pilot study of psilocybin with psychological support in 20 patients with treatment resistant depression that demonstrated the feasibility of delivering this treatment in this group of patients. The current study is a randomised, placebo controlled trial of psilocybin in up to 60 participants with treatment resistant depression. The objective is to test the feasibility of the randomised, controlled trial design with this drug in this patient group, to collect safety data and to estimate how many participants we would need for a larger, definitive trial.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Psychological & Behavioural;
You can take part if:
You may not be able to take part if:
The following exclusion criteria will apply • Diagnosis of bipolar disorder (defined as meeting DSM-5 criteria for bipolar 1 or bipolar 2) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. • Diagnosis of psychotic disorder (defined as meeting DSM-5 criteria for any psychotic disorder) on the MINI 7.0, EXCEPT substance/medication induced psychotic disorder where the duration was limited to the acute period of direct intoxication with the substance/medication. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. • Diagnosis of drug or alcohol dependence syndrome (defined as meeting DSM-5 criteria for any dependence syndrome) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. • Diagnosis of any personality disorder (defined as meeting DSM-5 criteria for any personality disorder) based on clinical interview and the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. • Diagnosis of any dementia (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist. • Personal history of a > = 1 suicide attempt in the past year requiring hospitalization, defined using the CSSRS (Q6 (past year) = “y”) and confirmation at clinical interview with a psychiatrist. • Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin. • Depression secondary to other medical conditions • Medical diagnosis incompatible with psilocybin treatment (see Section 6.2.1) • Inability to provide a screening blood sample, urine sample or electrocardiogram. • Biochemical abnormalities (defined as falling outside the normal reference range) as evaluated by a full blood count, full biochemistry profile and thyroid function tests. Biochemical abnormalities must also be determined as clinically significant by a medical doctor to fulfil the criterion for exclusion. • Electrocardiographic abnormalities, defined as any abnormality that is not normal sinus rhythm and determined as clinically significant by a medical doctor. • Women of child bearing potential not using adequate contraception (see Section 6.2.2). • Pregnant or breast-feeding women. • Those unable to give informed consent. • Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held. • Those enrolled in another drug trial
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Tim
Mantingh
Tim.mantingh@kcl.ac.uk
Prof
Allan
Young
allan.young@kcl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by King's College London and funded by NIHR Academy .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 41425
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