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The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 12 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | Flexible-dosed (5 to 20 mg Oral Tablets Daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I) | The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S) | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact viaH. Lundbeck A/S viaH. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RU001 | Moscow | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram (5 to 20 mg Oral Tablets Daily) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram (5 to 20 mg Oral Tablets Daily) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I) | The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | Posted | Mean | Standard Deviation | scores on a scale | baseline and 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Escitalopram (5 to 20 mg Oral Tablets Daily) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | H. Lundbeck A/S | email contact via | Lundbeck | LundbeckClinicalTrials@lundbeck.com |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D003909 | Dexetimide |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| baseline and 12 weeks |
| Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2 | The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | baseline and 12 weeks |
| Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2 | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | baseline and 12 weeks |
| Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | baseline and 12 weeks |
| Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | baseline and 12 weeks |
| Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | baseline and 12 weeks |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| CGI Severity Score | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | Mean | Standard Deviation | scores on a scale |
|
| Sheehan Disability Scale (SDS) Work | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean | Standard Deviation | scores on a scale |
|
| Sheehan Disability Scale (SDS) Family | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean | Standard Deviation | scores on a scale |
|
| Sheehan Disability Scale (SDS) Social | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean | Standard Deviation | scores on a scale |
|
|
| Secondary | Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S) | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | Posted | Mean | Standard Deviation | scores on a scale | baseline and 12 weeks |
|
|
|
| Secondary | Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2 | The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | Posted | Number | percentage of patients | baseline and 12 weeks |
|
|
|
| Secondary | Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2 | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | Posted | Number | percentage of patients | baseline and 12 weeks |
|
|
|
| Secondary | Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Due to data being unavailable, 22 participants were analysed for this outcome, in contrast with 30 participants for the other outcomes. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 12 weeks |
|
|
|
| Secondary | Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 12 weeks |
|
|
|
| Secondary | Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 12 weeks |
|
|
|
| 0 |
| 30 |
| 16 |
| 30 |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
No results can be made public before appropriate steps by Lundbeck to secure patents / intellectual property rights. The Investigator shall send any manuscript / public presentation to Lundbeck at least 1 month before submission for publication. If Lundbeck finds matters requiring patents or the like, the Investigator shall delay publication / public presentation for an additional 3 months.
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |