Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305500
Status:
COMPLETED
Last Update Posted:
2006-07-26
First Post:
2006-03-21
Brief Title:
Tolerability and Efficacy of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder OCD
Sponsor:
Abarbanel Mental Health Center
Organization:
Abarbanel Mental Health Center
Study Overview
Official Title:
Phase III Open Study of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder in Adults
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives To evaluate tolerability and efficacy of escitalopram treatment in high dose than 20-50 mgd in out-patients with OCD Type of the study Open label prospective study
Number of patients 100 patients with OCD
Duration of the study 18-weeks of active treatment 8-visits
Dose titration
One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment- if partialno response according to YBOCS score and clinical judgment dose increase of up to 50mg depending on response adverse events patient preference and judgment of the clinician 12 weeks follow up on high dose Total of 18 weeks of follow-up
Number of patients 100 patients with OCD
Duration of the study 18-weeks of active treatment 8-visits
Dose titration
One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment- if partialno response according to YBOCS score and clinical judgment dose increase of up to 50mg depending on response adverse events patient preference and judgment of the clinician 12 weeks follow up on high dose Total of 18 weeks of follow-up
Detailed Description:
Objectives To evaluate tolerability and efficacy of escitalopram treatment in doses higher than 20mg 20-50 mgd in patients with OCD non responsive or partially responsive to recommended doses
Type of the study Open label prospective study Study location Subjects will be recruited from patients treated in a large clinic specializing in mood disorders and anxiety and OCD
Backup site the ABARBANEL mental health center Number of patients 100 patients with OCD
Duration of the study 18-weeks of active treatment 8-visits
Dose titration
One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment- if partialno response according to YBOCS score and clinical judgment dose increase of up to 50mg depending on response adverse events patient preference and judgment of the clinician 12 weeks follow up on high dose Total of 18 weeks of follow-up
Patients
Inclusion Criteria
1 Men and women over 18 years of age
2 DSM IV-TR criteria for OCD
3 OCD associated with most distress or most interference in the patients life as judged by the treating physician
4 Yale-Brown Obsessive Compulsive Scale YBOCS total score 16
Exclusion Criteria
1 Other primary or co-primary psychiatric disorder which is more distressful for the patient then the OCD as evaluated by investigator
2 Patients with any history of maniabipolar disorder
3 Patients using medications which are contraindicated with the use of escitalopram
4 Known contraindication for the use of citalopram or escitalopram
5 Unable to understand and give informed consent
6 Prominent suicidal ideation 2 points or more in the MADRS suicidal thoughts item
7 Alcohol or substance dependence in the past 6 months
8 Major physical illness
9 a woman currently pregnant or less then 4 weeks after a childbirth Or b woman lactating Or c A woman of childbearing potential not using a medically accepted form of contraception
10 Liver function abnormality
11 EKG abnormalities
Study Design
An institutional review board acknowledged by the Israeli Ministry of Health will approve the study After complete description of the study to the patients written informed consent will be obtained from patients found eligible and willing to participate The design will be open-labeled The study will last for 18 weeks
Patients will be evaluated by clinical assessment and by various questionnaires see rating scales section Those who will be diagnosed as having OCD and will fulfill the inclusion and exclusion criteria requirements will start 4 weeks of initial treatment with escitalopram up to 20mgd After 4 weeks those patients who will be evaluated as non-responders reduction of Y-BOCS total score by less than 25 will continue treatment with higher escitalopram dose
Dose will be adjusted according to clinical status and the clinicians judgment up to 50mgd of escitalopram Patients will be evaluated periodically throughout the study for adverse reactions and psychiatric status by various rating scales as well as a clinical evaluation by the investigator
Assessments
1 Yale-Brown Obsessive Compulsive Scale Y-BOCS Symptom Checklist
2 Montgomery Åsberg Depression Rating Scale MADRS
3 The Clinical Global Impression scales CGI consist of two sub-scales
The Severity of illness CGI-S and the Global improvement CGI-I
4 A checklist of serotonergic specific adverse drug reactions dizziness bleeding and ecchymoses checklist
5 Visual Analog Scale VAS for assessment of mental well-being at every visit
6 SDS Sheehan Disability Scale
7 Recent and concomitant medications at every visit
Type of the study Open label prospective study Study location Subjects will be recruited from patients treated in a large clinic specializing in mood disorders and anxiety and OCD
Backup site the ABARBANEL mental health center Number of patients 100 patients with OCD
Duration of the study 18-weeks of active treatment 8-visits
Dose titration
One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment- if partialno response according to YBOCS score and clinical judgment dose increase of up to 50mg depending on response adverse events patient preference and judgment of the clinician 12 weeks follow up on high dose Total of 18 weeks of follow-up
Patients
Inclusion Criteria
1 Men and women over 18 years of age
2 DSM IV-TR criteria for OCD
3 OCD associated with most distress or most interference in the patients life as judged by the treating physician
4 Yale-Brown Obsessive Compulsive Scale YBOCS total score 16
Exclusion Criteria
1 Other primary or co-primary psychiatric disorder which is more distressful for the patient then the OCD as evaluated by investigator
2 Patients with any history of maniabipolar disorder
3 Patients using medications which are contraindicated with the use of escitalopram
4 Known contraindication for the use of citalopram or escitalopram
5 Unable to understand and give informed consent
6 Prominent suicidal ideation 2 points or more in the MADRS suicidal thoughts item
7 Alcohol or substance dependence in the past 6 months
8 Major physical illness
9 a woman currently pregnant or less then 4 weeks after a childbirth Or b woman lactating Or c A woman of childbearing potential not using a medically accepted form of contraception
10 Liver function abnormality
11 EKG abnormalities
Study Design
An institutional review board acknowledged by the Israeli Ministry of Health will approve the study After complete description of the study to the patients written informed consent will be obtained from patients found eligible and willing to participate The design will be open-labeled The study will last for 18 weeks
Patients will be evaluated by clinical assessment and by various questionnaires see rating scales section Those who will be diagnosed as having OCD and will fulfill the inclusion and exclusion criteria requirements will start 4 weeks of initial treatment with escitalopram up to 20mgd After 4 weeks those patients who will be evaluated as non-responders reduction of Y-BOCS total score by less than 25 will continue treatment with higher escitalopram dose
Dose will be adjusted according to clinical status and the clinicians judgment up to 50mgd of escitalopram Patients will be evaluated periodically throughout the study for adverse reactions and psychiatric status by various rating scales as well as a clinical evaluation by the investigator
Assessments
1 Yale-Brown Obsessive Compulsive Scale Y-BOCS Symptom Checklist
2 Montgomery Åsberg Depression Rating Scale MADRS
3 The Clinical Global Impression scales CGI consist of two sub-scales
The Severity of illness CGI-S and the Global improvement CGI-I
4 A checklist of serotonergic specific adverse drug reactions dizziness bleeding and ecchymoses checklist
5 Visual Analog Scale VAS for assessment of mental well-being at every visit
6 SDS Sheehan Disability Scale
7 Recent and concomitant medications at every visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None