E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obsessive Compulsive Disorder |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049596 |
E.1.2 | Term | Obsession |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010219 |
E.1.2 | Term | Compulsions |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate aripirazol (Abilify) as an augmenting strategy of sertraline treatment for children and adolescents with OCD who are treatment refractory to evidence based treatments. Status as treatment refractory is defined by lack of adequate response to Cognitive Behavioural Therapy (CBT) followed by an adequate trial of Sertraline plus continued CBT-support. Arpiprazol has unique pharmacological properties due to dopamine stabilising and mixed Serotonin agonistic and blocking actions (depending on 5-HT receptor subtype) that will augment the effect of sertraline on OCD. |
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E.2.2 | Secondary objectives of the trial |
To identify predictors, moderators and mediators of good and non- or partial Aripiprazole plus Sertraline response in treatment refractory pediatric OCD-patients. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Molecular genetic aspects of Obsessive Compulsive Disorder (OCD) and OCD treatment response: Objective: to identify genetic markers that (1) are characteristic of pediatric OCD patients (trio-design); (2) identify genetic markers that are characteristic of CBT responders and CBT non- or partial responders; (3) identify genetic markers that are characteristic of Sertraline responders respectively non-responders to CBT non- or partial responders: (4) identify genetic markers of sertraline+aripirazole response.
"Magnetkameraundersökning av glutamat/glutamin-koncentrationen i hjärnan vid tvångstillstånd" (OCD: Objective: to investigate functional brain abnormalities in pediatric OCD using Magnet resonance spectroscopy (MRS) in parts of the Cortici-Strtiatal. Thamalic-Cortical loops that are believed to be the one where the brain substrate of the OCD symptoms are situated. MRS can be used to identify glutamat concentration of the various parts of this functional loop. Also, substances that are associated with the vitality of components in the loop can be guaged.
Backgroundsfactors and outcome in pediatric OCD: Objective to study various correlates and possible backgroundsfactors, e.g. psychosocial and psychiatric co-morbidity and OCD symptom patterns etc. in pediatric OCD. Also, evaluating various scales and interviews used in pediatric OCD. |
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E.3 | Principal inclusion criteria |
Obsessive Compulsive Disorder according to DSM IV of moderate-severe type in patients aged 7-17. Severity as defined by Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Scores of 16 or above. All co-morbidities are allowed except as defined below. All patients included in step 3, involving Aripirazole have failed an adequate trial of CBT for 14 sessions (in step 1 and if applicable in step 2) and a subsequent adequate trial of sertraline, i.e. that CY-BOCS scores are still 16 or above. Thus, the patient has OCD that is treatment refractory to evidence based treatments, which is the inclusion criterion for step 3 of the NordLOTS. |
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E.4 | Principal exclusion criteria |
The patient has been adequately treated with CBT or Sertraline in the 6 months preceding inclusion in step 1 for OCD. Other psychiatric disorder with higher treatment priority (e.g. acute psychosis, suicidality in major depression, severe Anorexia nervosa). Mental retardation, Autism and Asperger's syndrome. Patient and/or parent does not understand or can speak the language. Comorbidity with ADHD, bipolar disorder etc are allowed if the patient is stabilised on the appropriate drug for at least 3 months. |
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E.5 End points |
E.5.1 | Primary end point(s) |
CYBOCS scores at 8 weeks and 3 months after inclusion in step 3. Responder status as good is defined as the patient having reduced their CYBOCS scores to 11-15 points. Excellent response is defined as CY-BOCS scores of 10 or below. Responders will be followed up for up to 36 months (from inclusion in step 1) (at +12, +24 and +36 months counted from inclusion in step 1) using the CY-BOCS and the stability of the treatment gains can thus be established. We will as well investigate the possibility to terminate the medication without relapse (Aripiprazole first followed by sertraline) using the same criteria. The Clinical Global Impression (CGI) and Clinical global Improvement (CGIimp) will be used at the same timepoints. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Dr Pål Zeiner M.D., Ph.D. , BUP, Drammen, Norway is the trial monitor with full access to data and powers to stop the trial. He is not part of the NordLOTS study or NordLOTS steering group.
If the trial monitor finds that the treatment (i.e. Aripiprazole) in step 3 leads to inadequate outcome and that no sub-groups have markedly better response the monitor is to stop the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 3 |