Panic DisorderNCT00004834
Randomized Study of Cognitive-Behavioral Therapy vs Imipramine and Their Combination for Panic Disorder
A study testing imipramine and cognitive-behavioral therapy in people with Panic Disorder, run by Northwell Health.
Trial summary
OBJECTIVES: I. Determine which treatment is most effective for patients with panic disorder: cognitive-behavioral therapy (CBT) plus imipramine (IMI), CBT plus placebo, CBT alone, IMI alone, or placebo alone. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- imipramine and cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 326 participants
- Where
- No sites listed yet
- Study dates
- May 1998to Jun 2005
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Principal diagnosis of panic disorder with or without mild agoraphobia, confirmed using the Anxiety Disorders Interview Schedule-Revised
- At least one full or limited panic attack per week within 2 weeks prior to initial assessment and 2 weeks prior to treatment
--Prior/Concurrent Therapy--
- Drug washout required if on anxiolytic or antidepressant medication No more than 10 benzodiazepine doses (0.5 mg alprazolam equivalent) within 2 weeks prior to treatment No more than 20 doses of benzodiazepine during baseline and acute treatment combined No more than one dose of benzodiazepine per day permitted
- No concurrent competing treatment
--Patient Characteristics--
- Not pregnant Negative serum pregnancy test required Effective contraception required of fertile women No psychotic, bipolar, or significant medical illnesses Not suicidal No significant substance abuse No prior nonresponse to either study treatment or related treatments No concurrent disability claims
About this study
OBJECTIVES:
- Determine which treatment is most effective for patients with panic disorder: cognitive-behavioral therapy (CBT) plus imipramine (IMI), CBT plus placebo, CBT alone, IMI alone, or placebo alone.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to receive one of five treatments: cognitive-behavioral therapy (CBT) alone, imipramine plus medical management (IMI), CBT plus IMI, pill placebo plus medical management (PLA), or CBT plus PLA.
Patients are seen by therapists for 11 sessions over 12 weeks (3 sessions during days 1-10 followed by 6 weekly sessions and 2 biweekly sessions). Each CBT session lasts approximately 1 hour, each IMI session lasts approximately 30 minutes, and patients in combined treatment see 2 therapists for a total of about 80 minutes. Oral IMI or placebo is taken daily.
Patients not responding to placebo or IMI after the initial 12 weeks are offered alternative treatment for up to 3 months or given a referral; responders continue to be treated monthly for the next 6 months. This is followed by a washout period of 6 months, after which patients receive final assessment. All therapy and assessment sessions are video- or audiotaped.
Patients are interviewed by an independent evaluator at the start of treatment and 3, 9, and 15 months later, and must keep a set of weekly self-monitoring forms. In addition, patients complete rating forms and questionnaires, and undergo carbon dioxide measurement at the start of treatment and 3, 9, and 15 months later.
At study conclusion, patients are told which medication they received and receive treatment recommendations.
- Conditions
- Panic Disorder
- Being tested
- imipramine, cognitive-behavioral therapy
- Keywords
- anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease
- Medical subject headings
- Panic Disorder, Anxiety Disorders, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imipramineDrug
cognitive-behavioral therapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startMay 1998
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 326 participants
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Long Island Jewish Medical Center
- Responsible party
- Sponsor
- Investigators
- Jack M. Gorman, Study chair, Long Island Jewish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004834
- Sponsor's protocol ID
- 199/13462
- Other IDs
- R10MH045963, R10MH045965, R10MH045964, R10MH045966
- Status last verified
- Feb 2013
- First submitted
- 24 Feb 2000
- Last updated
- 21 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Cognitive-Behavioral Therapy vs Imipramine and Their Combination for Panic Disorder
- ClinicalTrials.gov ID
- NCT00004834
- Acronym / sponsor ID
- 199/13462
- Conditions
- Panic Disorder
- Keywords
- anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Long Island Jewish Medical Center
- Study start
- May 1998
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 25 Feb 2000 (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.
OBJECTIVES:
- Determine which treatment is most effective for patients with panic disorder: cognitive-behavioral therapy (CBT) plus imipramine (IMI), CBT plus placebo, CBT alone, IMI alone, or placebo alone.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to receive one of five treatments: cognitive-behavioral therapy (CBT) alone, imipramine plus medical management (IMI), CBT plus IMI, pill placebo plus medical management (PLA), or CBT plus PLA.
Patients are seen by therapists for 11 sessions over 12 weeks (3 sessions during days 1-10 followed by 6 weekly sessions and 2 biweekly sessions). Each CBT session lasts approximately 1 hour, each IMI session lasts approximately 30 minutes, and patients in combined treatment see 2 therapists for a total of about 80 minutes. Oral IMI or placebo is taken daily.
Patients not responding to placebo or IMI after the initial 12 weeks are offered alternative treatment for up to 3 months or given a referral; responders continue to be treated monthly for the next 6 months. This is followed by a washout period of 6 months, after which patients receive final assessment. All therapy and assessment sessions are video- or audiotaped.
Patients are interviewed by an independent evaluator at the start of treatment and 3, 9, and 15 months later, and must keep a set of weekly self-monitoring forms. In addition, patients complete rating forms and questionnaires, and undergo carbon dioxide measurement at the start of treatment and 3, 9, and 15 months later.
At study conclusion, patients are told which medication they received and receive treatment recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| imipramine | Drug | – |
| cognitive-behavioral therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
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 21 Feb 2013.
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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.
Jack M. Gorman study chair
Long Island Jewish Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing imipramine and cognitive-behavioral therapy in people with Panic Disorder, run by Northwell Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
Where can I read the original study information?
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 21 Feb 2013.