OCD Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

This trial covers six different conditions. A person may be considered if they fall into one of the following groups:

Group 1 – Obsessive-Compulsive Disorder (OCD) that has not responded to treatment:

• Adults aged 18 to 65 with a diagnosis of OCD (as defined by standard diagnostic guidelines called DSM-5)
• People whose OCD has not improved after trying at least 3 different SSRI medications, plus at least 2 different second-generation antipsychotic medications at proper doses for a proper length of time, or who could not tolerate these treatments
• People who have also completed more than 8–12 sessions of talking therapy (Cognitive Behaviour Therapy/CBT), or who were unable to tolerate it
• People with a high OCD symptom score (Y-BOCS score of 25 or above) at the start of the trial
• People with a high illness severity rating (CGI-S score of 4 or above) at the start of the trial
• People (and their guardian, where applicable) who fully understand and agree to the brain implant procedure and sign a consent form

Group 2 – Schizophrenia that has not responded to treatment:

• Adults aged 18 to 65 with a DSM-5 diagnosis of schizophrenia, present for 5 or more years
• People whose schizophrenia has not improved after trying at least 2 different antipsychotic medications (not including clozapine) at adequate doses for at least 12 weeks each, or who could not tolerate them; OR people who tried clozapine at an adequate dose for at least 12 weeks without improvement or who could not tolerate it
• People with a high symptom score (PANSS score of 70 or above) and specific symptom severity ratings at the start of the trial (confirm with trial site)
• People with a high illness severity rating (CGI-S score of 4 or above) at the start of the trial
• People with a low general functioning score (GAF score of 60 or below) at the start of the trial
• People (and their guardian, where applicable) who fully understand and agree to the brain implant procedure and sign a consent form

Group 3 – Bipolar disorder with depression that has not responded to treatment:

• Adults aged 18 to 65 with a DSM-5 diagnosis of Bipolar I or Bipolar II disorder, currently in a depressive episode, with the condition present for 2 or more years
• People who have tried at least two specific approved medications (such as Quetiapine, Lurasidone, Lamotrigine, or others listed in the criteria) at proper doses for at least 8 weeks each without achieving full symptom relief for 8 consecutive weeks; OR tried one of those medications combined with another listed mood stabiliser, also without sufficient improvement (confirm with trial site for exact combinations)
• People who have also had at least 12 sessions of electroconvulsive therapy (ECT) without benefit, or who could not tolerate it
• People who have been in a depressive episode for at least 12 weeks leading up to the trial
• People with a high depression score (MADRS score of 26 or above), a high illness severity rating, and a mood score within a specific range at the start of the trial (confirm with trial site)
• People (and their guardian, where applicable) who fully understand and agree to the brain implant procedure and sign a consent form

Group 4 – Anorexia nervosa that has not responded to treatment:

• Adults aged 18 to 65 with a DSM-5 diagnosis of anorexia nervosa (either restricting type or binge-eating/purging type)
• People with a BMI between 10 and 16 at the time of screening and at the start of the trial
• People whose condition has been present for 5 or more years, who have been hospitalised 3 or more times with poor outcomes (unable to complete treatment or relapsing immediately afterwards)
• People who have tried nutritional treatment, medication (SSRIs and/or antipsychotics), and psychological therapies (such as intensive CBT or family-based therapy) without improvement or who could not tolerate these
• People whose condition has been clinically unstable and worsening for more than 1 year, with 2 or more instances of involuntary feeding required
• People (and their guardian, where applicable) who fully understand and agree to the brain implant procedure and sign a consent form

Group 5 – Gambling disorder:

• Adults aged 18 to 65 with a DSM-5 diagnosis of moderate or severe gambling disorder (meeting 6 or more diagnostic criteria), with the condition present for 2 or more years
• People who have received structured treatment (such as medication and social/psychological support) but continue to experience strong urges to gamble or ongoing gambling behaviour
• People (and their guardian, where applicable) who fully understand and agree to the brain implant procedure and sign a consent form

Group 6 – Autism spectrum disorder in adults:

• Adults aged 18 to 65 with a DSM-5 diagnosis of autism spectrum disorder, who have severe, life-threatening repetitive behaviours confirmed by two independent psychiatrists
• People with a high autism behaviour score (AuBC score of 62 or above) and a high illness severity rating (CGI-S score of 4 or above) at the start of the trial
• People whose condition has been present for 10 or more years and who have not benefited from structured behavioural interventions or training programmes, or who could not tolerate them
• People (and their guardian, where applicable) who fully understand and agree to the brain implant procedure and sign a consent form

Who may not be able to join:

• People who have certain other mental health conditions, such as paranoid personality disorder or an intellectual disability
• People assessed by the trial doctors as being at significant risk of suicide
• People whose symptoms improve notably between the initial screening and the start of the trial (for example, a 20% or greater improvement in key symptom scores or functioning measures relevant to their condition)
• People with serious or unstable problems affecting the heart, lungs, liver, kidneys, blood, hormone system, nervous system, or other major body systems
• People with neurological conditions such as a brain disease, brain injury, or epilepsy that has not responded to treatment
• People with significant abnormal results on physical examination, blood tests, heart (ECG) tests, or brain imaging, where the trial doctors consider this to be clinically important
• People who have an implanted device such as a cochlear implant or pacemaker, or who have had another surgical procedure within the past 6 months that the trial doctors consider relevant to this study
• People for whom brain implant surgery is medically unsuitable, as determined by the trial doctors
• People who have tested positive for HIV
• People who are pregnant, breastfeeding, or have a positive pregnancy test; people who are unable to use effective contraception during the trial; or people planning to become pregnant within 3 months of the trial starting
• People who are currently participating in another clinical trial of a medication or medical device, or who have done so within 3 months before the screening period
• People considered unsuitable for any other reason by the trial doctors

Important: Always verify eligibility with the trial site directly before applying.