A Phase 2 interventional study of Rituximab in Obsessive-Compulsive Disorder, Obsessive-Compulsive Behavior and Schizophrenia, sponsored by Uppsala University Hospital. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Uppsala University Hospital · Phase 2, Interventional, and Treatment
The primary objective for this study is to evaluate whether Rituximab as compared to placebo is a clinically effective treatment for a subgroup of patients suffering from psychosis and/or obsessive-compulsive disorder (OCD) or -behavior (OCB) where there is an indication of immune system involvement.
The secondary objectives of this study are
The exploratory objectives of this study are
METHODOLOGY:
This study is planned as a placebo-controlled, interventional study of parallel groups with 40 participants. Patients will be randomized to either treatment-first arm with 500 mg Rituximab i.v. (infusion 1) at 0 and again at 4 months (infusion 2), or placebo-first arm, receiving NaCl-infusion at 0 and at 4 months. Main evaluation will take place at eight months. The study arms are switched after eight months, i.e. patients starting in the treatment-first arm will receive placebo (NaCl) infusions at 8 months (infusion 3) and 12 months (infusion 4), and patients in the placebo-first arm receive 500 mg-Rituximab infusions at these time points. Final evaluation is scheduled at 16 months. Before each infusion, all patients in the Rituximab and control groups are pre-treated with injection Solu-Medrol 125 mg, i.v., tablet Paracetamol 1000 mg, p.o. and tablet Cetirizin 10 mg, orally.
Patients will be monitored with psychiatric rating scales and blood samples at baseline and every four months. In addition, baseline (-1 months), main (8 months) and final evaluation (16 months) will encompass collection of CSF (lumbar puncture), psychologic testing and extended blood samples. Patient, nurse administering treatment and symptom evaluators are blinded to group randomization.
INVESTIGATIONAL PRODUCT, DOSAGE AND MODE OF ADMINISTRATION:
Duration of treatment:
Patients are observed over the course of 16 months. Main evaluation is conducted after 8 months. Participants are randomized to either treatment-first (Rituximab infusion at 0 months and 4 months) or placebo-first (Rituximab infusion at 8 months and 12 months).
SITE MONITORING AND SOURCE DATA VERIFICATION
The Investigator(s)/institution(s) will permit study-related monitoring, audits, review and regulatory inspection(s), providing access to source data/hospital records. Sponsor verifies that each patient has consented in writing to direct access to the original source data/hospital records by the use of written patient information and signed Informed Consent.
In accordance with the principles of Good Clinical Practice (GCP), monitoring of the study will be arranged by the Sponsor. During the study, the Monitor will have regular contacts with the study site(s), including visits to ensure that the study is conducted and documented properly in compliance with the protocol, GCP and applicable regulatory requirements.
Prior to the start of the study, the monitor will review the protocol and CRFs with the investigator and his/her staff. The investigator will be visited by the monitor, who will check study procedures, including safety assessments, study medication handling, and data recording.
To assure the accuracy and completeness of the data recorded in the trial, the monitor will compare Case Report Forms (CRFs) with medical records and other relevant documentation during the on-site monitoring visits (source data verification, SDV). The monitor will have direct access to all source data according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP. Incorrect or missing entries into the CRFs will be queried and must be corrected. Any discrepancies of data will be documented and explained in the monitoring reports. Study monitoring will not jeopardize patient confidentiality.
The study center may also be subject to inspection by the Swedish Medical Products Agency (MPA). The Investigator and other responsible personnel must be available during the monitoring visits and a possible inspection, and should devote sufficient time to these processes.
DATA COLLECTION AND MANAGEMENT
Data management and handling of data will be conducted according to the study specific Data Management Plan with ICH guidelines and an assigned CRO's standard operating procedures (SOPs). An electronic CRF (eCRF) system will be used to capture data from the study. Data entry will be performed by the study site personnel. Validation and data queries will be handled by the CRO's Data Management Team. The data will be subjected to validation according to the CRO's SOPs in order to ensure accuracy in the collected CRF data.The CRF will have an audit trail with appropriate functionality for data capture, tracking and documentation of any queries or changes. Electronic signatures will be used to lock the data and identify the person entering or changing the data.
Before database closure a reconciliation will be performed between the Serious Adverse Events (SAEs) entered in the safety database and the study database. After database closure, the database will be exported as Statistical Analysis System (SAS®) data sets. Any discrepancies and additions from the process defined in the Data Management Plan, will be described in a study specific Data Management Report.
STATISTICAL ANALYSIS:
The trial comprises a fully blinded randomized part, up to and including the 8 month visit, and a follow-up part, with preserved blinding but where it is known that the patient has received Rituximab treatment either in the fully blinded part of the trial or in the follow-up part. The main treatment comparisons will be based on the fully blinded 8 months of the trial, analyzed as a parallel group trial as described below. Data from the follow-up part will be presented descriptively and will be used for explorative modelling of treatment response and duration.
ANALYSIS POPULATION:
The full analysis set (FAS) will consist of all randomized patients that received at least one dose of investigational treatment, and will be used for all analyses unless specified. The number of patients with available data for each outcome analysis will be tabulated. In baseline-adjusted analyses, patients that lack baseline data will be excluded.
DESCRIPTIVE STATISTICS:
Brief Psychiatric Rating Scale (BPRS) score over time, for both parts of the trial, will be described using time series plots of individual data and randomized treatment arm mean values. BPRS and BPRS linear change from baseline at each time point will be described by randomized treatment using dot plots, scatter plots with baseline value on the x-axis, and tables of mean, standard deviation, median, min, max and quartiles.
PRIMARY ANALYSIS:
The primary outcome, BPRS at 8 months, will primarily be analyzed using a linear model with randomized treatment and baseline BPRS as covariates, and presented as the mean difference between the treatment groups with 95% confidence interval (CI) and two-sided p-value. Primarily the analysis will be based on observed cases, which gives unbiased estimation under a mechanism with random missingness conditional on baseline BPRS and treatment arm.
SENSITIVITY ANALYSES:
To address missing data,
BPRS at four months will be analyzed using the same method as for the primary time point, including sensitivity analyses. The main purpose of the four-month measurement is exploration of time to response.
SECONDARY EFFICACY OUTCOMES:
All analyses will be performed without formal multiplicity adjustment, for observed cases.
CGI-S over time will be presented by individual time series plots, and for each visit by number and percentage of patients in each category, and of patients satisfying the criteria for response (at least 2-point reduction from baseline), partial response (a 1 point reduction from baseline), and remission (CGI-S score 1-3). The categorical outcome response/partial response/no response will be analysed using logistic regression with randomized treatment as the only factor and presented as the common odds ratio with 95% CI and 2-sided p-value, at 8 months (primary time point) and at 4 months. Remission at the same time points will be analysed using logistic regression and presented as odds ratios with 95% CI and 2-sided p-value.
World Health Organization Disability Assessment Schedule (WHODAS) results will be presented as domain scores based on item response theory based scoring, and total disability score. Domain and total scores over time will be described using individual time series plots and mean value plots by randomized treatment. Domain and total scores, and linear change from baseline scores, at each time point will be described by randomized treatment using dot plots, scatter plots with baseline value on the x-axis, and tables of mean, standard deviation, median, min, max and quartiles. Total disability score at 8 months (primary) and 4 months will be analysed using a linear model with randomized treatment and baseline score as covariates and presented as mean difference with 95% CI and 2-sided p-value.
Yale Brown Obsessive Compulsion Scale (Y-BOCS) results will be presented and analyzed in the same way as WHODAS disability score. In addition, the number and proportion of patients with score 15 or below will be presented and analyzed in the same way as remission defined by CGI-S.
Bush-Francis Catatonia Rating Scale (BFCRS) total score over time will be described using individual time series plots and mean value plots by randomized treatment. Domain and total scores, and linear change from baseline scores, at each time point will be described by randomized treatment using dot plots, scatter plots with baseline value on the x-axis, and tables of mean, standard deviation, median, min, max and quartiles.
Pittsburgh Sleep Quality Index (PSQI) global sum will be tabulated descriptively by randomized treatment for each time point, using mean, standard deviation, median, quartiles, min and max, and number and percentage of patients with global sum 5 or higher.
EuroQol-5D (EQ-5D) domain scores will be presented for each time point using descriptive frequency tables and stacked bar charts by randomized treatment. EQ-5D Visual Analogue Scale (VAS) scale scores will be presented for each time point using descriptive tables of mean, standard deviation, median, min, max and quartiles.
Mismatch Negativity (MMN) amplitude and latency will be measured as the most negative data point within the 80-130 ms latency window, post-stimulus onset and compared between time points.
Biomarkers over time will be presented descriptively using individual time series plots and plots of geometric mean values over time by randomized treatment, and for each visit scatter plots with baseline on the x-axis and tables of geometric mean, geometric coefficient of variation (CV), median, quartiles, min and max, based on values over the limit of quantification, and number of observations under the limit of quantification. For infusion safety markers, the number and proportion of patients with values outside normal will also be tabulated. Biomarker concentrations at 8 months (primary) and 4 months will be analysed using a linear model for the log-transformed biomarker with randomized treatment and log-transformed baseline biomarker as covariates, and presented as the geometric mean ratio with 95% CI and two-sided p-value.
DETERMINATION OF SAMPLE SIZE Within- and between-patient standard deviation was estimated to 7.1 and 6.7 points respectively, from five case series with in total 35 measurements pre- and post-rituximab treatment, using a linear mixed-effect model with random intercept and rituximab treatment as a fixed factor.
Power was estimated using simulation. Baseline and 8 months BPRS were simulated with a 7 point standard deviation (SD) normally distributed random variation both within and between patients (corresponding to a total SD=9.8 points for a single measurement), and a homogenous treatment effect, using R v. 3.3.1. 40 patients, 20 patients per group, would give 81% power to detect an 8 point adjusted mean difference in BPRS between the rituximab and placebo groups, and 89% power to detect a difference of 9 points. Reasonable power would be retained under 5% random drop-out, with 79% power to detect an 8 point difference and 87% power to detect a 9 point difference between the groups. The power to detect a 9 point difference would still be 85% with 10% random drop-out.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 40 is below the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Uppsala University Hospital is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General criteria
Diagnostic criteria: ICD 10 at least one of the following ICD 10 diagnoses:
F20 Schizophrenia
F22 Delusional disorders
F23 Brief psychotic disorder
F25 Schizoaffective disorders
F28 Other psychotic disorder not due to a substance or known physiological condition
F29 Unspecified psychosis not due to a substance or known physiological condition
The clinical picture indicates active inflammatory activity (see specific criteria below), potential for rehabilitation and time from disease and/or episode debut is no longer than 10 years.
Specific criteria
Acute (\<12 weeks) or atypical debut, or episodes of any of the following:
Symptoms of encephalopathy:
psychotic symptoms, including hallucinations, delusions, paranoia, disorganized speech, disorganized behavior
agitation, confusion
sudden change in personality as perceived by the social environment
drowsiness
loss of functions in daily Life
cognitive problems (memory, speech, learning)
emotional dysregulation
AND
At least one of the following criteria:
Biochemical evidence of inflammation, autoimmunity or blood-brain barrier dysfunction in blood or CSF samples, such as one of the following:
presence of oligoclonal bands
elevated CSF cell count
elevated albumin quotient, or elevated albumin in CSF
elevated Immunoglobulin G (IgG) ratio
elevated levels of neurofilament
EXCLUSION CRITERIA
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive i.v. infusions with 500 mg Rituximab at 0 and 4 months, followed by placebo infusions (NaCl) at 8 and at 12 months, Pre-treatment prior to all four infusions consists of injection Solu-Medrol 125 mg i.v., tablet Paracetamol 1000 mg p.o. and tablet Cetirizin 10 mg p.o.
Drug: Rituximab
Participants receive placebo (NaCl) i.v. infusions at 0 and 4 months, followed by 500-mg-Rituximab infusions at 8 and 12 months. Pre-treatment prior to all four infusions consists of injection Solu-Medrol 125 mg i.v., tablet Paracetamol 1000 mg p.o. and tablet Cetirizin 10 mg p.o.
Drug: Rituximab
Rituximab 500 mg, dissolved in 250 ml NaCl in an infusion bag, covered with non-see-through plastic * administered iv over a course of max 180 minutes * at 0 and 4 months (treatment-first arme) OR at 8 and 12 months (placebo-first arm)
BPRS
Brief Psychiatric Rating Scale, is a broad psychiatric interview and evaluation tool comprising 24 items, of which 14 are rated based on the individual´s self-report, and ten based on observed behavior and speech. Each item is rated 1 to 7 (1 = not present, 7 = extremely severe). Minimum score with all items assessed is 24, maximum score is 168. Higher score signifies higher degree of psychiatric symptoms i.e. worse outcome. Primary outcome measure is the mean difference in total score between the trial arms at 8 months.
Time frame: 8 months
WHODAS
World Heath Organization Disability Assessment Schedule (36 questions self-rated by participant). Each item is assigned a score from 1 ("none") to five ("extreme"). Minimum score is 36, maximum score 180 with higher score meaning worse outcome.
Time frame: baseline, 4 months, 8 months, 12 months, 16 months
CGI
Clinical global impressions of severity (CGI-S) and improvement (CGI-I) as rated by investigator. Severity of illness (CGI-S) is rated from 1 = "normal, not ill" to 7 = "among the most extremely ill patients", i.e. higher score means worse outcome. Global improvement (CGI-I) is rated from 1 = "Very much improved" to 7 = "Very much worse" i.e. higher score meaning worse outcome.
Time frame: baseline, 4 months, 8 months, 12 months, 16 months
EQ-VAS
EuroQol Visual analogue scale; measures self-rated health on a visual analogue scale. Score ranges from 0 to 100, with higher score meaning better outcome.
Time frame: baseline, 4 months, 8 months, 12 months, 16 months
Y-BOCS
Yale Brown Obsessive Compulsive Scale; using 10-item investigator-administered assessment of the frequency of obsessions and compulsions. Each item is scored from 0 to 4, with higher score indicating more severe symptoms i.e. worse outcome. Minimum score is 0, maximum is 40.
Time frame: baseline, 4 months, 8 months, 12 months, 16 months
BFCRS
Bush Francis Catatonia Rating Scale, an investigator-rated 23-item scale for catatonic signs and their severity. Each item is rated from 0 to 3 (items 13, 17, 18, 19, 20 and 21 can only be assigned 0 or 3), with higher score indicating more severe symptoms, i.e. worse outcome. Minimum score is 0, maximum is 69.
Time frame: baseline, 4 months, 8 months, 12 months, 16 months
MMN
Mismatch negativity (MMN); measuring differences in brain reactions to infrequently ("deviant") vs frequently occuring ("standard") auditory stimuli. EEG is recorded during a 12-minute session with the patient listening to an odd-ball paradigm of 1440 standard tones and 360 duration variants. 400 ms-windows are averaged and the maximum difference in negativity between standards and deviants is recorded as the MMN. MMN amplitude and latency will be measured as the most negative data point within the 80-130 ms latency window, post-stimulus onset and compared between time points. Previous data is not available for this population.
Time frame: baseline, 8 months, 16 months
Neurological exam
The following items will be examined and judged normal or abnormal. Outcome is change in number of pathological items over time. More abnormal items means worse outcome. * dysarthria * dysphasia * verbal coherence * awareness of person, place and time * involuntary movements * walking pattern * heel-to-toe gait * heel walking and toe walking * squatting and raising up * knee extension * tone of knee joints, elbows, wrists * reflexes: patellar, achilles, biceps, triceps * plantar response (Babinski´s sign) * heel-to-shin-test * finger-to-nose test * diadochokinesis * light-touch sensation on hands and feet * pin-prick sensation on hands and feet * vibration sensation on ankles and wrists * eye movement (including nystagmus, ptosis) * pupil size and reaction to light * Donder´s field-of-view-test * friction sound hearing test * facial motor functions * uvula asymmetry * tongue motor functions * finger and shoulder abduction * Grassets test * Rombergs test
Time frame: baseline, 8 months, 16 months
Change in plasma/serum and CSF markers for immune activity
The concentration of diverse markers for immune activity e.g. autoantibodies, cytokines, chemokines, immunoregulatory molecules, will be measured at baseline, 8 months and 16 months. Biomarker concentrations over time will be presented descriptively using individual time series plots, and plots of geometric mean values over time by randomized treatment. The exact biomarkers to be analyzed will be specified before data collection for this study is completed and before the code is broken.
Time frame: baseline, 8 months, 16 months
BPRS
Brief Psychiatric Rating Scale, is a broad psychiatric interview and evaluation tool comprising 24 items, of which 14 are rated based on the individual´s self-report, and ten based on observed behavior and speech. Each item is rated 1 to 7 (0 = not assessed, 1 = not present, 7 = extremely severe). Minimum score with all items assessed is 24, maximum score is 168. Higher score signifies higher degree of psychiatric symptoms i.e. worse outcome. BPRS at 4, 12 and 16 months will be analyzed using the same method as for the primary time point.
Time frame: 4 months, 12 months, 16 months
SWM
CANTAB digital version of Spatial Working Memory (SWM). Among a number of digital colored squares, participants are to find yellow tokes and use them to fill up an empty column. Outcome is measured by number of errors (revisiting squares), with higher error number meaning worse outcome.
Time frame: baseline, 8 months, 16 months
RTI
CANTAB digital version of Reaction Time (RTI). Participants must react as soon as possible to indicate a yellow dot that appears in one of five circles. Outcome measures are divided into reaction time and movement time. Longer time means worse outcome.
Time frame: baseline, 8 months, 16 months
PAL
CANTAB digital version of paired associates learning (PAL). Several boxes displayed on a screen. Some of them contain a pattern. Participants must allocate a displayed pattern to the correct box. Outcome is measured by number of errors (higher number means worse outcome), number of trials required to locate pattern(s) correctly (higher number means worse outcome), memory scores (higher score means better outcome) and stages completed (more stages means better outcome).
Time frame: baseline, 8 months, 16 months
MTT
CANTAB digital version of Multitasking Test (MTT). The test displays an arrow which can appear on either the right or left side of the screen, and can point either to the right or to the left. A cue at the top of the screen indicates to the participant which rule they are to follow to select the right or left button: either according to "the side on which the arrow appeared" or according to "the direction in which the arrow was pointing". Outcome measures include response latencies and error scores. Longer latency and higher error score mean worse outcome.
Time frame: baseline, 8 months, 16 months
OTS
CANTAB digital version of One Touch Stockings of Cambridge (OTS). The participant is shown an upper and a lower display containing three colored balls each. The participant is to work out in their head how many moves that are required to copy the pattern in the upper display to the lower display. Outcome measures are number of problems solved on first choice (higher number means better outcome), mean choices to correct (higher number means worse outcome), speed of response to first choice (if the first choice was correct, longer time means worse outcome) and mean latency to correct (loger latency means worse outcome)
Time frame: baseline, 8 months, 16 months
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