E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obsessive Compulsive disorder |
|
E.1.1.1 | Medical condition in easily understood language |
Obsessive Compulsive disorder |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029898 |
E.1.2 | Term | Obsessive-compulsive disorder |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
|
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 |
Primary aim with the study is to investigate whether D-Cycloserine (DCS) gives incremental effects to Internet-based cognitive behavior therapy (ICBT) in terms of reduced Obsessive Compulsive Disorder (OCD) symptoms at post-treatment and follow-up. |
|
E.2.2 | Secondary objectives of the trial |
Secondary aims are to a) replicate previous findings in that DCS fastens the effects of ICBT, b) correlate the fastened effect to overall treatment adherence and c) investigate gene variation and therapeutic factors as predictors of symptom severity, symptom type and treatment response. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Outpatients • Male or female • ≥ 18 years • Currently living in Stockholm, Uppland, Örebro, Södermanland, Gästrikland, Västmanland and Östergötland county in Sweden. • Primary diagnosis of OCD according to the DSM-IV-TR. • Signed informed consent • Have regular access to a computer with internet access and skills to use the web • Have received information about the need of using contraception
|
|
E.4 | Principal exclusion criteria |
• Pregnancy or breast feeding • Patients unlikely to cooperate fully in the study • Patients not able to read or understand the basics of the ICBT self-help material • Psychotropic medication changes within two months prior to treatment • Completed CBT for OCD within last 12 months • Y-BOCS [21] < 16 at Psychiatrist visit (6.2.3)pi • OCD symptoms primarily associated with hoarding. • Other primary axis I diagnosis according to the Mini-International Neuropsychiatric Interview (MINI) [34] • Ongoing substance dependence • Lifetime bipolar disorder or psychosis • Suicidal ideation • Axis II diagnosis that could jeopardize treatment participation • Serious physical illness that will be an obstacle in ICBT and DCS • Other ongoing psychological treatments that could affect OCD symptoms • Epilepsia • Renal impairment • Hypersensitivity to D-Cycloserine • Porphyria • Chronic Alcoholism
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The clinician rated Yale Brown Obsessive-Compulsive Scale total score expressed as the change from baseline to last post-baseline value. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline (W0) Post-treatment (W13) Short-term follow-up (3 months after completion of treatment) Long-term follow-up (12 months after completion of treatment) Long-term follow-up (24 months after completion of treatment) |
|
E.5.2 | Secondary end point(s) |
• Yale Brown Obsessive-Compulsive Scale (Y-BOCS) self-rating. • Obsessive Compulsive Inventory – Revised (OCI-R). • Montgomery Åsberg Depression Rating Scale – Self report (MADRS-S). • Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P). • Euroqol (EQ-5D). • Global Assessment of Functioning (GAF). • Clinical Global Impression (CGI). • Remission status according to the Structured Clinical Interview for DSM-IV (SCID-I) criteria for OCD.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline (W0) Post-treatment (W13) Short-term follow-up (3 months after completion of treatment) Long-term follow-up (12 months after completion of treatment) Long-term follow-up (24 months after completion of treatment) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
Blinding will be broken when the last subject has completed the 3-month follow-up assessment. The whole trial will end when the last subject has completed the 24-month follow-up assessment. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |