Anxiety DisorderPhase 1CAP-ENCT01293838
Cipralex® for Anxiety Disorders in Adolescents
A Phase 1 study testing Cipralex® in people with Anxiety Disorder, run by University of Ottawa at 1 site in Canada.
Trial summary
The primary objective is to examine whether Cipralex® is effective and safe in the treatment of anxiety disorders in youth. The secondary objective is to identify changes in arousal and stress response from pre- to post-treatment with Cipralex® in youth with anxiety disorders. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- Cipralex®
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary diagnosis of (1 or more)
- Social Phobia
- Generalized Anxiety Disorder
- Separation Anxiety Disorder
- Panic Disorder
- Comorbid depression allowed
Who cannot join
- Unstable medical condition
- Substance use disorder
- Current diagnosis of OCD
- Lifetime diagnosis of developmental delay, pervasive developmental disorder, psychosis
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, K1Z 7K4
Chantelle McEwen, MA, 613-722-6521 ext. 6194, chantelle.mcewen@rohcg.on.ca
Meagan Birmingham, MA, 613-722-6521 ext. 7193, meagan.birmingham@rohcg.on.ca
About this study
Official title: Cipralex® for Anxiety Disorders in Adolescents: Clinical and Physiological Changes Associated With Open Label, Flexible-dose Treatment
The primary objective is to examine whether Cipralex® is effective and safe in the treatment of anxiety disorders in youth. The secondary objective is to identify changes in arousal and stress response from pre- to post-treatment with Cipralex® in youth with anxiety disorders.
Read the detailed description
Anxiety disorders are the most common mental illnesses of adolescence, with an overall prevalence ranging from 5.0% to 10.8% (Costello et al, 1996; Ford et al, 2003; Fergusson et al, 1993; Shaffer et al, 1996; Verhulst et al., 1997). Six- to 12-month prevalence has been estimated to be 0.5-2.4% for separation anxiety disorder (SAD), 2.1-4.6% for overanxious disorder (OAD), the DSM-III antecedent of generalized anxiety disorder (GAD), 1.7-6.9% for social phobia (SP), and 0.3-1.2% for panic disorder (PD) (Bowen et al, 1990; Fergusson et al, 1993; Ford et al, 2003; Lewinsohn et al, 1993; Romano et al, 2001; Verhulst et al, 1997). In the US National Comorbidity Survey, the median age of onset for anxiety disorders was 11 years (range 6-21 years), which was much younger than for substance use disorders (20 years) and mood disorders (30 years) (Kessler, 2005). However, anxious youth often go undiagnosed and untreated, possibly because they tend to be compliant and nondisruptive (Esser et al, 1990). This is of concern since research suggests that youth with untreated anxiety disorders are more likely to develop significant problems later in life, such as continued anxiety, depression, substance abuse, suicide attempts, educational underachievement, and impaired psychosocial functioning (Pine et al, 1998; Woodward \& Fergusson, 2001).
The existing literature on pharmacological treatment of anxiety disorders in adolescents is limited, but suggests that the selective serotonin reuptake inhibitors (SSRIs) are the treatment of choice for pervasive and impairing anxiety disorders in youth (Reinblatt \& Walkup, 2005). A few randomized controlled trials (RCT) provide support for the use of SSRIs such as fluvoxamine and fluoxetine for the treatment of SAD, GAD and SP. Cipralex® is a newer SSRI whose use for treatment of anxiety disorders in adolescents has been documented in only one previous open trial (Isolan et al., 2007). Results from this study and a few RCTs conducted in adults with anxiety disorders suggest that Cipralex® should be effective and safe for relieving symptoms of anxiety in adolescents.
Primary objectives: (1) to assess the clinical and psychosocial changes associated with 16-week open-label treatment with Cipralex® (10 to 20 mg/day) in adolescents with SAD, SP, PD and/or GAD; (2) to assess the tolerance and safety of Cipralex® (10 to 20 mg/day for 16 weeks) in adolescents with SAD, SP, PD and/or GAD.
Secondary objective: (1) to investigate changes in physiological measures of arousal and stress response (i.e., heart rate variability, salivary concentrations of cortisol and alpha-amylase, acoustic startle response,) using standardized laboratory stressors, before and after treatment with Cipralex® (10 to 20 mg/day for 16 weeks) in youth with anxiety disorders.
- Conditions
- Anxiety Disorder
- Being tested
- Cipralex®
- Keywords
- Adolescents, Anxiety Disorder, Cipralex, Social Phobia, Separation Anxiety Disorder, Panic Disorder, Generalized Anxiety Disorder, physiological arousal, stress response, salivary cortisol, salivary alpha-amylase, heart rate variability
- Medical subject headings
- Anxiety Disorders, Phobia, Social, Anxiety, Separation, Panic Disorder, Generalized Anxiety Disorder, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cipralex®Drug
Also called Chemical/Pharmaceutical alternative name: Escitalopram
Based on a starting rate of 5 mg/day, increased by 5 mg every 2 weeks to a maximum of 20 mg/day for weeks 7-16, each participant will receive up to:
- 10 mg tablets: 28
- 20 mg tablets: 84
Total for 30 participants:
- 10 mg tablets: 840
- 20 mg tablets: 2520
Continuation study for participants who respond to Cipralex - Across 12 weeks, each participant will receive up to:
*20 mg tablets: 84
Total for continuation study for all participants (assuming a 60% response rate, N=18):
*20 mg tablets: 1512
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy
Measures used to assess treatment efficacy:
- The Anxiety Disorders Interview Schedule for DSM-IV, Research and Lifetime Version for Children and Parents (Silverman \& Albano, 1996)
- Multidimensional Anxiety Scale for Children (March et al., 1997)
- Youth Quality of Life Scale (Topolski et al., 2001),
- Pediatric Anxiety Rating Scale (RUPP, 2002)
- Beck Depression Inventory-2 (Beck et al., 1996
- Behavioral and Emotional Rating Scale-2 (Epstein \& Sharma, 2004),
- Clinical Global Impression Scale-Severity and Improvement (Guy, W. \& ECDEU, 1976)
Measured: At week 16
Secondary outcomes (2)
Physiological response to stress
- Trier Social Stress Task for Children (TSST-C)[Baseline and week 18]
- Salivary cortisol[For baseline, samples will be collected in the home upon awakening/8 am, +30, +60 min, at 4 pm, and at 8 pm on 2 consecutive weekdays. Cortisol will also be measured from samples collected before and after the TSST-C(-1, +10, +20, +30, +45, and +60 min)]
- Salivary alpha-amylase[Before (-1), and +1, +10, +20, and +30 min after the TSST-C]
- Heart rate variability[Baseline and during the TSST-C]
- Acoustic Startle Response[Baseline and in a "fear-potentiated" condition with an ASR system]
- Urine drug test
Measured: At week 18 - see below
Suicide risk
At each treatment visit, the clinician will elicit AEs and SAEs, and complete the Columbia-Suicide Severity Rating Scale (C-SSRS) (Posner et al, 2007)
Measured: Each treatment visit (baseline then weeks 2, 4, 6, 8, 12, 16, 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startMar 2008
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Investigators
- Martine Flament, MD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293838
- Sponsor's protocol ID
- IMHR REB#2007036
- Other IDs
- 123485
- Acronym
- CAP-E
- Status last verified
- Jan 2011
- First submitted
- 10 Feb 2011
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Posner K, Melvin GA, Stanley B, Oquendo MA, Gould M. Factors in the assessment of suicidality in youth. CNS Spectr. 2007 Feb;12(2):156-62. doi: 10.1017/s1092852900020678.
PubMed 17277716Costello EJ, Angold A, Burns BJ, Stangl DK, Tweed DL, Erkanli A, Worthman CM. The Great Smoky Mountains Study of Youth. Goals, design, methods, and the prevalence of DSM-III-R disorders. Arch Gen Psychiatry. 1996 Dec;53(12):1129-36. doi: 10.1001/archpsyc.1996.01830120067012.
PubMed 8956679Fergusson DM, Horwood LJ, Lynskey MT. Prevalence and comorbidity of DSM-III-R diagnoses in a birth cohort of 15 year olds. J Am Acad Child Adolesc Psychiatry. 1993 Nov;32(6):1127-34. doi: 10.1097/00004583-199311000-00004.
PubMed 8282656Shaffer D, Fisher P, Dulcan MK, Davies M, Piacentini J, Schwab-Stone ME, Lahey BB, Bourdon K, Jensen PS, Bird HR, Canino G, Regier DA. The NIMH Diagnostic Interview Schedule for Children Version 2.3 (DISC-2.3): description, acceptability, prevalence rates, and performance in the MECA Study. Methods for the Epidemiology of Child and Adolescent Mental Disorders Study. J Am Acad Child Adolesc Psychiatry. 1996 Jul;35(7):865-77. doi: 10.1097/00004583-199607000-00012.
PubMed 8768346Verhulst FC, van der Ende J, Ferdinand RF, Kasius MC. The prevalence of DSM-III-R diagnoses in a national sample of Dutch adolescents. Arch Gen Psychiatry. 1997 Apr;54(4):329-36. doi: 10.1001/archpsyc.1997.01830160049008.
PubMed 9107149Bowen RC, Offord DR, Boyle MH. The prevalence of overanxious disorder and separation anxiety disorder: results from the Ontario Child Health Study. J Am Acad Child Adolesc Psychiatry. 1990 Sep;29(5):753-8. doi: 10.1097/00004583-199009000-00013.
PubMed 2228929Lewinsohn PM, Hops H, Roberts RE, Seeley JR, Andrews JA. Adolescent psychopathology: I. Prevalence and incidence of depression and other DSM-III-R disorders in high school students. J Abnorm Psychol. 1993 Feb;102(1):133-44. doi: 10.1037//0021-843x.102.1.133.
PubMed 8436689Romano E, Tremblay RE, Vitaro F, Zoccolillo M, Pagani L. Prevalence of psychiatric diagnoses and the role of perceived impairment: findings from an adolescent community sample. J Child Psychol Psychiatry. 2001 May;42(4):451-61.
PubMed 11383961Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
PubMed 15939837Esser G, Schmidt MH, Woerner W. Epidemiology and course of psychiatric disorders in school-age children--results of a longitudinal study. J Child Psychol Psychiatry. 1990 Jan;31(2):243-63. doi: 10.1111/j.1469-7610.1990.tb01565.x.
PubMed 2312652Woodward LJ, Fergusson DM. Life course outcomes of young people with anxiety disorders in adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Sep;40(9):1086-93. doi: 10.1097/00004583-200109000-00018.
PubMed 11556633Reinblatt SP, Walkup JT. Psychopharmacologic treatment of pediatric anxiety disorders. Child Adolesc Psychiatr Clin N Am. 2005 Oct;14(4):877-908, x. doi: 10.1016/j.chc.2005.06.004.
PubMed 16171707Isolan L, Pheula G, Salum GA Jr, Oswald S, Rohde LA, Manfro GG. An open-label trial of escitalopram in children and adolescents with social anxiety disorder. J Child Adolesc Psychopharmacol. 2007 Dec;17(6):751-60. doi: 10.1089/cap.2007.0007.
PubMed 18315447March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554-65. doi: 10.1097/00004583-199704000-00019.
PubMed 9100431Topolski TD, Patrick DL, Edwards TC, Huebner CE, Connell FA, Mount KK. Quality of life and health-risk behaviors among adolescents. J Adolesc Health. 2001 Dec;29(6):426-35. doi: 10.1016/s1054-139x(01)00305-6.
PubMed 11728892
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cipralex® for Anxiety Disorders in Adolescents: Clinical and Physiological Changes Associated With Open Label, Flexible-dose Treatment
- ClinicalTrials.gov ID
- NCT01293838
- Acronym / sponsor ID
- CAP-E / IMHR REB#2007036
- Conditions
- Anxiety Disorder
- Keywords
- Adolescents, Anxiety Disorder, Cipralex, Social Phobia, Separation Anxiety Disorder, Panic Disorder, Generalized Anxiety Disorder, physiological arousal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Mar 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to examine whether Cipralex® is effective and safe in the treatment of anxiety disorders in youth. The secondary objective is to identify changes in arousal and stress response from pre- to post-treatment with Cipralex® in youth with anxiety disorders.
Detailed description
Anxiety disorders are the most common mental illnesses of adolescence, with an overall prevalence ranging from 5.0% to 10.8% (Costello et al, 1996; Ford et al, 2003; Fergusson et al, 1993; Shaffer et al, 1996; Verhulst et al., 1997). Six- to 12-month prevalence has been estimated to be 0.5-2.4% for separation anxiety disorder (SAD), 2.1-4.6% for overanxious disorder (OAD), the DSM-III antecedent of generalized anxiety disorder (GAD), 1.7-6.9% for social phobia (SP), and 0.3-1.2% for panic disorder (PD) (Bowen et al, 1990; Fergusson et al, 1993; Ford et al, 2003; Lewinsohn et al, 1993; Romano et al, 2001; Verhulst et al, 1997). In the US National Comorbidity Survey, the median age of onset for anxiety disorders was 11 years (range 6-21 years), which was much younger than for substance use disorders (20 years) and mood disorders (30 years) (Kessler, 2005). However, anxious youth often go undiagnosed and untreated, possibly because they tend to be compliant and nondisruptive (Esser et al, 1990). This is of concern since research suggests that youth with untreated anxiety disorders are more likely to develop significant problems later in life, such as continued anxiety, depression, substance abuse, suicide attempts, educational underachievement, and impaired psychosocial functioning (Pine et al, 1998; Woodward \& Fergusson, 2001).
The existing literature on pharmacological treatment of anxiety disorders in adolescents is limited, but suggests that the selective serotonin reuptake inhibitors (SSRIs) are the treatment of choice for pervasive and impairing anxiety disorders in youth (Reinblatt \& Walkup, 2005). A few randomized controlled trials (RCT) provide support for the use of SSRIs such as fluvoxamine and fluoxetine for the treatment of SAD, GAD and SP. Cipralex® is a newer SSRI whose use for treatment of anxiety disorders in adolescents has been documented in only one previous open trial (Isolan et al., 2007). Results from this study and a few RCTs conducted in adults with anxiety disorders suggest that Cipralex® should be effective and safe for relieving symptoms of anxiety in adolescents.
Primary objectives: (1) to assess the clinical and psychosocial changes associated with 16-week open-label treatment with Cipralex® (10 to 20 mg/day) in adolescents with SAD, SP, PD and/or GAD; (2) to assess the tolerance and safety of Cipralex® (10 to 20 mg/day for 16 weeks) in adolescents with SAD, SP, PD and/or GAD.
Secondary objective: (1) to investigate changes in physiological measures of arousal and stress response (i.e., heart rate variability, salivary concentrations of cortisol and alpha-amylase, acoustic startle response,) using standardized laboratory stressors, before and after treatment with Cipralex® (10 to 20 mg/day for 16 weeks) in youth with anxiety disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Primary diagnosis of (1 or more)
- Social Phobia
- Generalized Anxiety Disorder
- Separation Anxiety Disorder
- Panic Disorder
Key exclusion criteria (4 listed)
- Unstable medical condition
- Substance use disorder
- Current diagnosis of OCD
- Lifetime diagnosis of developmental delay, pervasive developmental disorder, psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cipralex®Also: Chemical/Pharmaceutical alternative name: EscitalopramBased on a starting rate of 5 mg/day, increased by 5 mg every 2 weeks to a maximum of 20 mg/day for weeks 7-16, each participant will receive up to: * 10 mg tablets: 28 * 20 mg tablets: 84 Total for 30 participants: * 10 mg tablets: 840 * 20 mg tablets: 2520 Continuation study for participants who respond to Cipralex - Across 12 weeks, each participant will receive up to: *20 mg tablets: 84 Total for continuation study for all participants (assuming a 60% response rate, N=18): *20 mg tablets: 1512 | Drug | – |
Primary outcome
Treatment Efficacy
Time frame: At week 16
Measures used to assess treatment efficacy: * The Anxiety Disorders Interview Schedule for DSM-IV, Research and Lifetime Version for Children and Parents (Silverman \& Albano, 1996) * Multidimensional Anxiety Scale for Children (March et al., 1997) * Youth Quality of Life Scale (Topolski et al., 2001), * Pediatric Anxiety Rating Scale (RUPP, 2002) * Beck Depression Inventory-2 (Beck et al., 1996 * Behavioral and Emotional Rating Scale-2 (Epstein \& Sharma, 2004), * Clinical Global Impression Scale-Severity and Improvement (Guy, W. \& ECDEU, 1976)
2 secondary outcomes
Physiological response to stress
Time frame: At week 18 - see below
Suicide risk
Time frame: Each treatment visit (baseline then weeks 2, 4, 6, 8, 12, 16, 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
- Background: PubMed 17277716Posner K, Melvin GA, Stanley B, Oquendo MA, Gould M. Factors in the assessment of suicidality in youth. CNS Spectr. 2007 Feb;12(2):156-62. doi: 10.1017/s1092852900020678.
- Background: PubMed 8956679Costello EJ, Angold A, Burns BJ, Stangl DK, Tweed DL, Erkanli A, Worthman CM. The Great Smoky Mountains Study of Youth. Goals, design, methods, and the prevalence of DSM-III-R disorders. Arch Gen Psychiatry. 1996 Dec;53(12):1129-36. doi: 10.1001/archpsyc.1996.01830120067012.
- Background: PubMed 8282656Fergusson DM, Horwood LJ, Lynskey MT. Prevalence and comorbidity of DSM-III-R diagnoses in a birth cohort of 15 year olds. J Am Acad Child Adolesc Psychiatry. 1993 Nov;32(6):1127-34. doi: 10.1097/00004583-199311000-00004.
- Background: PubMed 8768346Shaffer D, Fisher P, Dulcan MK, Davies M, Piacentini J, Schwab-Stone ME, Lahey BB, Bourdon K, Jensen PS, Bird HR, Canino G, Regier DA. The NIMH Diagnostic Interview Schedule for Children Version 2.3 (DISC-2.3): description, acceptability, prevalence rates, and performance in the MECA Study. Methods for the Epidemiology of Child and Adolescent Mental Disorders Study. J Am Acad Child Adolesc Psychiatry. 1996 Jul;35(7):865-77. doi: 10.1097/00004583-199607000-00012.
- Background: PubMed 9107149Verhulst FC, van der Ende J, Ferdinand RF, Kasius MC. The prevalence of DSM-III-R diagnoses in a national sample of Dutch adolescents. Arch Gen Psychiatry. 1997 Apr;54(4):329-36. doi: 10.1001/archpsyc.1997.01830160049008.
- Background: PubMed 2228929Bowen RC, Offord DR, Boyle MH. The prevalence of overanxious disorder and separation anxiety disorder: results from the Ontario Child Health Study. J Am Acad Child Adolesc Psychiatry. 1990 Sep;29(5):753-8. doi: 10.1097/00004583-199009000-00013.
- Background: PubMed 8436689Lewinsohn PM, Hops H, Roberts RE, Seeley JR, Andrews JA. Adolescent psychopathology: I. Prevalence and incidence of depression and other DSM-III-R disorders in high school students. J Abnorm Psychol. 1993 Feb;102(1):133-44. doi: 10.1037//0021-843x.102.1.133.
- Background: PubMed 11383961Romano E, Tremblay RE, Vitaro F, Zoccolillo M, Pagani L. Prevalence of psychiatric diagnoses and the role of perceived impairment: findings from an adolescent community sample. J Child Psychol Psychiatry. 2001 May;42(4):451-61.
- Background: PubMed 15939837Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
- Background: PubMed 2312652Esser G, Schmidt MH, Woerner W. Epidemiology and course of psychiatric disorders in school-age children--results of a longitudinal study. J Child Psychol Psychiatry. 1990 Jan;31(2):243-63. doi: 10.1111/j.1469-7610.1990.tb01565.x.
- Background: PubMed 11556633Woodward LJ, Fergusson DM. Life course outcomes of young people with anxiety disorders in adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Sep;40(9):1086-93. doi: 10.1097/00004583-200109000-00018.
- Background: PubMed 16171707Reinblatt SP, Walkup JT. Psychopharmacologic treatment of pediatric anxiety disorders. Child Adolesc Psychiatr Clin N Am. 2005 Oct;14(4):877-908, x. doi: 10.1016/j.chc.2005.06.004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Flament, MD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cipralex® in people with Anxiety Disorder, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine Flament, MD (613-722-6521 ext. 6455, martine.flament@rohcg.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Efficacy (time frame: At week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01293838, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.