Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), 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 8 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).
Not provided
Not provided
Not provided
Not provided
| 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 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA) | The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56. | baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Escitalopram After 8 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 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RU001 | Moscow | Russia |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram (5 to 20 mg Oral Tablets Daily) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| 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 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA) | The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 8 weeks |
|
|
8 weeks
Not provided
Not provided
| 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) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | H. Lundbeck A/S | Email contact via | Lundbeck | LundbeckClinicalTrials@lundbeck.com |
Not provided
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D003909 | Dexetimide |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Effect of Escitalopram After 8 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). | baseline and 8 weeks |
| Percentage of Patients Who Responded to Escitalopram After 8 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 8 weeks |
| Percentage of Patients Who Achieved Remission After 8 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 8 weeks |
| Effect of Escitalopram After 8 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 scale, on which 0 = normal functioning and 10 = severe functional impairment. | baseline and 8 weeks |
| Effect of Escitalopram After 8 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 scale, on which 0 = normal functioning and 10 = severe functional impairment. | baseline and 8 weeks |
| Effect of Escitalopram After 8 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 scale, on which 0 = normal functioning and 10 = severe functional impairment. | baseline and 8 weeks |
| Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score | The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56. | baseline and 8 weeks |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Hamilton Anxiety Scale (HAMA) | The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56. | Mean | Standard Deviation | scores on a scale |
|
| Clinical Global Impression Severity (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). | 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 scale, 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 scale, 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 scale, on which 0 = normal functioning and 10 = severe functional impairment. | Mean | Standard Deviation | scores on a scale |
|
|
| Secondary | Effect of Escitalopram After 8 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 8 weeks |
|
|
|
| Secondary | Effect of Escitalopram After 8 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 8 weeks |
|
|
|
| Secondary | Percentage of Patients Who Responded to Escitalopram After 8 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 8 weeks |
|
|
|
| Secondary | Percentage of Patients Who Achieved Remission After 8 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 8 weeks |
|
|
|
| Secondary | Effect of Escitalopram After 8 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 scale, on which 0 = normal functioning and 10 = severe functional impairment. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 8 weeks |
|
|
|
| Secondary | Effect of Escitalopram After 8 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 scale, on which 0 = normal functioning and 10 = severe functional impairment. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 8 weeks |
|
|
|
| Secondary | Effect of Escitalopram After 8 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 scale, on which 0 = normal functioning and 10 = severe functional impairment. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 8 weeks |
|
|
|
| Secondary | Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score | The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56. | Observed Cases (OC) | Posted | Number | percentage of patients | baseline and 8 weeks |
|
|
|
| 0 |
| 30 |
| 13 |
| 30 |
| Headache | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
No results can be made public before appropriate steps by Lundbeck to secure patents and/or intellectual property rights. The Investigator shall send any manuscript and/or 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 and/or 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 |