Panic DisorderNCT00131339
Augmenting Exposure Therapy With an N-Methyl-D-Aspartate (NMDA) Agonist for Panic Disorder
A study testing Cognitive behavioral therapy and D-cycloserine in people with Panic Disorder, run by Hartford Hospital at 2 sites in United States.
Trial summary
This study involves cognitive behavioral therapy (CBT) and a medication called D-cycloserine (DCS), which is thought to help reduce panic symptoms more effectively by interacting with N-methyl-D-aspartate (NMDA) glutamate receptors, facilitating many forms of learning including the extinction of fear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Cognitive behavioral therapy and D-cycloserine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2004to Mar 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Principal diagnosis of panic disorder
Who cannot join
- History of psychotic disorders or bipolar disorder
- Substance dependence
- Pregnant or breastfeeding
- History of a medical condition that may increase the risks of taking the study drug
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, 02215
Hartford Hospital
Hartford, Connecticut, 06106
About this study
Official title: Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Panic Disorder
This study involves cognitive behavioral therapy (CBT) and a medication called D-cycloserine (DCS), which is thought to help reduce panic symptoms more effectively by interacting with N-methyl-D-aspartate (NMDA) glutamate receptors, facilitating many forms of learning including the extinction of fear. Participants will be randomly assigned (like flipping a coin) to receive either DCS or a placebo in addition to CBT.
Read the detailed description
This study consists of cognitive behavioral therapy (CBT) including exposure to physical sensations and feared situations, which have been demonstrated to be effective for many individuals with panic disorder.
All assessments and treatment sessions are free of charge. Half of the patients will be randomly assigned to receive D-cycloserine (DCS) and half wll be assigned to receive a placebo. Although DCS is used in humans to treat tuberculosis, it has not been FDA approved for this indication. Recent research in other anxiety disorders has shown that DCS plus behavior therapy is more effective than behavior therapy alone.
This treatment study had two active interventions. All patients will receive CBT and the researchers expect that everybody will improve from this treatment. However, it may be that those patients in the DCS intervention will improve somewhat more than those in the placebo intervention.
The treatment will be structured with at home practice and repeated assessments. Assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment. The treatment consists of 5 sessions (once a week) plus a one week post-treatment assessment and follow-up assessments at one month and six months.
- Conditions
- Panic Disorder
- Being tested
- Cognitive behavioral therapy, D-cycloserine
- Keywords
- panic disorder, cognitive behavioral therapy, D-cycloserine, medication, treatment trial, placebo-controlled, double-blind, randomized
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
D-cycloserineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
significant reduction in panic symptoms after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startNov 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Michael W. Otto, Ph.D., Principal investigator, Center for Anxiety and Related Disorders at Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131339
- Sponsor's protocol ID
- TOLI001428HI
- Status last verified
- Aug 2009
- First submitted
- 16 Aug 2005
- Last updated
- 26 Aug 2009
- Results posted
- No
Publications
Otto MW, Tolin DF, Simon NM, Pearlson GD, Basden S, Meunier SA, Hofmann SG, Eisenmenger K, Krystal JH, Pollack MH. Efficacy of d-cycloserine for enhancing response to cognitive-behavior therapy for panic disorder. Biol Psychiatry. 2010 Feb 15;67(4):365-70. doi: 10.1016/j.biopsych.2009.07.036. Epub 2009 Oct 6.
PubMed 19811776
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Panic Disorder
- ClinicalTrials.gov ID
- NCT00131339
- Acronym / sponsor ID
- TOLI001428HI
- Conditions
- Panic Disorder
- Keywords
- panic disorder, cognitive behavioral therapy, D-cycloserine, medication, treatment trial, placebo-controlled, double-blind, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Mar 2007 (actual)
- First posted
- 18 Aug 2005 (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.
This study involves cognitive behavioral therapy (CBT) and a medication called D-cycloserine (DCS), which is thought to help reduce panic symptoms more effectively by interacting with N-methyl-D-aspartate (NMDA) glutamate receptors, facilitating many forms of learning including the extinction of fear. Participants will be randomly assigned (like flipping a coin) to receive either DCS or a placebo in addition to CBT.
Detailed description
This study consists of cognitive behavioral therapy (CBT) including exposure to physical sensations and feared situations, which have been demonstrated to be effective for many individuals with panic disorder.
All assessments and treatment sessions are free of charge. Half of the patients will be randomly assigned to receive D-cycloserine (DCS) and half wll be assigned to receive a placebo. Although DCS is used in humans to treat tuberculosis, it has not been FDA approved for this indication. Recent research in other anxiety disorders has shown that DCS plus behavior therapy is more effective than behavior therapy alone.
This treatment study had two active interventions. All patients will receive CBT and the researchers expect that everybody will improve from this treatment. However, it may be that those patients in the DCS intervention will improve somewhat more than those in the placebo intervention.
The treatment will be structured with at home practice and repeated assessments. Assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment. The treatment consists of 5 sessions (once a week) plus a one week post-treatment assessment and follow-up assessments at one month and six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Principal diagnosis of panic disorder
Key exclusion criteria (4 listed)
- History of psychotic disorders or bipolar disorder
- Substance dependence
- Pregnant or breastfeeding
- History of a medical condition that may increase the risks of taking the study drug
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 |
|---|---|---|
| Cognitive behavioral therapy | Behavioural | – |
| D-cycloserine | Drug | – |
Primary outcome
significant reduction in panic symptoms after completion of treatment
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 26 Aug 2009.
- Derived from this study: PubMed 19811776Otto MW, Tolin DF, Simon NM, Pearlson GD, Basden S, Meunier SA, Hofmann SG, Eisenmenger K, Krystal JH, Pollack MH. Efficacy of d-cycloserine for enhancing response to cognitive-behavior therapy for panic disorder. Biol Psychiatry. 2010 Feb 15;67(4):365-70. doi: 10.1016/j.biopsych.2009.07.036. Epub 2009 Oct 6.
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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.
Michael W. Otto, Ph.D. principal investigator
Center for Anxiety and Related Disorders at Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy and D-cycloserine in people with Panic Disorder, run by Hartford Hospital at 2 sites 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 1 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: finished, as of the sponsor's last update on 26 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 2 sites 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.
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?
significant reduction in panic symptoms after completion of treatment. 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 NCT00131339, which also lists 1 linked publication.
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 26 Aug 2009.