Generalized Anxiety DisorderPhase 4NCT00438386
Aripiprazole for the Treatment of Refractory Anxiety
A Phase 4 study testing Aripiprazole in people with Generalized Anxiety Disorder and Panic Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether aripiprazole is effective in the treatment of refractory panic and generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Generalized Anxiety Disorder, Panic Disorder
- What is being tested?
- Aripiprazole
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2007
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female outpatients, age 18-75.
- Diagnosis of Generalized Anxiety Disorder (GAD) or Panic Disorder (PD) with or without Agoraphobia.
- For GAD: Hamilton Anxiety Rating Scale score greater than or equal to 16, and for PD: MGH Anchored Panic CGI Severity Rating greater than or equal to 4.
- Hamilton Depression Scale score less than or equal to 18.5) Clinical Global Impression of Severity score Score equal to or greater than 4.
- History of persistent anxiety despite at least 8 weeks of an adequate (or highest tolerated) dose of anxiolytic pharmacotherapy. This is operationalized to include an antidepressant (e.g., paroxetine 20 mg/d; imipramine 150 mg/d or phenelzine 60 mg/d or their equivalent) or a benzodiazepine (e.g., clonazepam 2 mg/d or its equivalent). The dose of medication should be stable for at least 2 weeks prior to evaluation.
- Willingness and ability to comply with the requirements of the study protocol.
Who cannot join
- Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).
- Patients with current or history of bipolar disorder, schizophrenia or other psychotic conditions.
- Patients with a history of alcohol or substance abuse or dependence within the last six months or a positive toxicology screen for drugs of abuse at baseline.
- Patients with significant unstable medical illness or illness which results in HPA axis dysregulation, or other neurohormonal dysregulation.
- Severe personality disorders likely to interfere with study participation.
- Ongoing psychotherapy directed toward the treatment of the primary anxiety disorder.
- History of hypersensitivity to aripiprazole, or > 1 previous treatment failure for anxiety with atypical antipsychotics. Concomitant treatment with other antipsychotics
- Patients exhibiting suicidality as evidenced by a score greater than 2 on item #3 of the HAM-D.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Aripiprazole for the Treatment of Refractory Anxiety: Impact on Clinical Outcomes, Resilience and Neuroendocrinologic Parameters
The purpose of this study is to determine whether aripiprazole is effective in the treatment of refractory panic and generalized anxiety disorder.
Read the detailed description
Accruing evidence demonstrates that the anxiety disorders are common and associated with significant morbidity and impairment. Although current first-line interventions are effective, many patients remain at least somewhat symptomatic, and some respond not at all, despite initial treatment. For instance, Generalized Anxiety Disorder (GAD) is a common distressing and disabling condition affecting 5% of the population. It is typically characterized by a chronic course and associated with significant psychosocial impairment and decreased quality of life (Simon and Pollack 2000). Although a number of therapeutic agents have demonstrated efficacy in the treatment of GAD, only a minority of anxious patients experience remission with initial treatment.
Panic disorder with or without agoraphobia is a common anxiety disorder, occurring in 3.5 % of the population (Kessler, et al., 1994). Although the study of panic disorder has advanced in recent years, with the availability of a growing number of treatments with reported efficacy in clinical trials and practice, acute and longitudinal follow-up studies of patients with panic disorder suggest that many individuals remain symptomatic despite treatment (Pollack and Otto, 1994). However, there is no systematic data currently available to guide the treatment of patients with panic disorder who remain symptomatic after initial intervention.
Thus, one purpose of this study is to examine the efficacy of the addition of aripiprazole, for the treatment of patients with GAD or panic disorder who remain refractory despite a treatment trial with an anxiolytic (e.g. antidepressant, benzodiazepine, buspirone). Aripiprazole is a novel antipsychotic agent with potent effects at the serotonergic, as well as dopaminergic receptor, and a more favorable side effect profile than standard neuroleptics, including a low potential to cause extrapyramidal symptoms.
The study period is a 9-week, acute treatment phase. Patients who meet inclusion criteria will receive aripiprazole for 8 weeks. Treatment will be initiated with 2.5 mg/day at the baseline visit, 5 mg/day aripiprazole for the first week and flexibly titrated up to a maximum of 30 mg/day over the next six weeks. Patients will be seen weekly for the first three weeks of this phase of treatment, and then at 2-week intervals for the remainder of the study.
- Conditions
- Generalized Anxiety Disorder, Panic Disorder
- Being tested
- Aripiprazole
- Keywords
- Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorder, Aripiprazole
- Medical subject headings
- Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale
Clinician Global Impression-Severity
Connor Davidson Resilience Scale
Secondary outcomes (1)
Panic Disorder Severity Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startApr 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Mark H Pollack, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438386
- Sponsor's protocol ID
- 2004-P-000935
- Status last verified
- Aug 2009
- First submitted
- 20 Feb 2007
- Last updated
- 10 Aug 2009
- Results posted
- No
Publications
Simon NM, Pollack MH. The Current Status of the Treatment of Panic Disorder: Pharmacotherapy and Cognitive-Behavioral Therapy. Psych Ann 30(11): 689-696, 2000.
Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.
PubMed 8279933Pollack, M, Otto, M. Long-Term Pharmacologic Treatment of Panic Disorder. Psychiatric Annals 24: 291-298, 1994.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole for the Treatment of Refractory Anxiety: Impact on Clinical Outcomes, Resilience and Neuroendocrinologic Parameters
- ClinicalTrials.gov ID
- NCT00438386
- Acronym / sponsor ID
- 2004-P-000935
- Conditions
- Generalized Anxiety Disorder, Panic Disorder
- Keywords
- Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorder, Aripiprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Feb 2007 (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 purpose of this study is to determine whether aripiprazole is effective in the treatment of refractory panic and generalized anxiety disorder.
Detailed description
Accruing evidence demonstrates that the anxiety disorders are common and associated with significant morbidity and impairment. Although current first-line interventions are effective, many patients remain at least somewhat symptomatic, and some respond not at all, despite initial treatment. For instance, Generalized Anxiety Disorder (GAD) is a common distressing and disabling condition affecting 5% of the population. It is typically characterized by a chronic course and associated with significant psychosocial impairment and decreased quality of life (Simon and Pollack 2000). Although a number of therapeutic agents have demonstrated efficacy in the treatment of GAD, only a minority of anxious patients experience remission with initial treatment.
Panic disorder with or without agoraphobia is a common anxiety disorder, occurring in 3.5 % of the population (Kessler, et al., 1994). Although the study of panic disorder has advanced in recent years, with the availability of a growing number of treatments with reported efficacy in clinical trials and practice, acute and longitudinal follow-up studies of patients with panic disorder suggest that many individuals remain symptomatic despite treatment (Pollack and Otto, 1994). However, there is no systematic data currently available to guide the treatment of patients with panic disorder who remain symptomatic after initial intervention.
Thus, one purpose of this study is to examine the efficacy of the addition of aripiprazole, for the treatment of patients with GAD or panic disorder who remain refractory despite a treatment trial with an anxiolytic (e.g. antidepressant, benzodiazepine, buspirone). Aripiprazole is a novel antipsychotic agent with potent effects at the serotonergic, as well as dopaminergic receptor, and a more favorable side effect profile than standard neuroleptics, including a low potential to cause extrapyramidal symptoms.
The study period is a 9-week, acute treatment phase. Patients who meet inclusion criteria will receive aripiprazole for 8 weeks. Treatment will be initiated with 2.5 mg/day at the baseline visit, 5 mg/day aripiprazole for the first week and flexibly titrated up to a maximum of 30 mg/day over the next six weeks. Patients will be seen weekly for the first three weeks of this phase of treatment, and then at 2-week intervals for the remainder of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female outpatients, age 18-75.
- Diagnosis of Generalized Anxiety Disorder (GAD) or Panic Disorder (PD) with or without Agoraphobia.
- For GAD: Hamilton Anxiety Rating Scale score greater than or equal to 16, and for PD: MGH Anchored Panic CGI Severity Rating greater than or equal to 4.
- Hamilton Depression Scale score less than or equal to 18.5) Clinical Global Impression of Severity score Score equal to or greater than 4.
- History of persistent anxiety despite at least 8 weeks of an adequate (or highest tolerated) dose of anxiolytic pharmacotherapy. This is operationalized to include an antidepressant (e.g., paroxetine 20 mg/d; imipramine 150 mg/d or phenelzine 60 mg/d or their equivalent) or a benzodiazepine (e.g., clonazepam 2 mg/d or its equivalent). The dose of medication should be stable for at least 2 weeks prior to evaluation.
Key exclusion criteria (8 listed)
- Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).
- Patients with current or history of bipolar disorder, schizophrenia or other psychotic conditions.
- Patients with a history of alcohol or substance abuse or dependence within the last six months or a positive toxicology screen for drugs of abuse at baseline.
- Patients with significant unstable medical illness or illness which results in HPA axis dysregulation, or other neurohormonal dysregulation.
- Severe personality disorders likely to interfere with study participation.
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 |
|---|---|---|
| Aripiprazole | Drug | – |
Primary outcome
Hamilton Anxiety Rating Scale
Clinician Global Impression-Severity
Connor Davidson Resilience Scale
1 secondary outcome
Panic Disorder Severity Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
- BackgroundSimon NM, Pollack MH. The Current Status of the Treatment of Panic Disorder: Pharmacotherapy and Cognitive-Behavioral Therapy. Psych Ann 30(11): 689-696, 2000.
- Background: PubMed 8279933Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.
- BackgroundPollack, M, Otto, M. Long-Term Pharmacologic Treatment of Panic Disorder. Psychiatric Annals 24: 291-298, 1994.
- The Center for Anxiety and Traumatic Stress Disorders at Massachusetts General HospitalLink provided by the sponsor.
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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.
Mark H Pollack, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole in people with Generalized Anxiety Disorder and Panic Disorder, run by Massachusetts General Hospital at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 10 Aug 2009. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale. The study lists 3 primary outcomes in all. 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 NCT00438386, which also lists 3 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 10 Aug 2009; AzTrials last refreshed its copy on 7 Nov 2026.