Panic DisorderPhase 3NCT01680107
D-cycloserine Augmented CBT for Panic Disorder
A Phase 3 study testing d-cycloserine and cognitive-behaviour therapy in people with Panic Disorder, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether d-cycloserine augments the clinical effects of exposure-based cognitive-behaviour therapy for panic disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- d-cycloserine and cognitive-behaviour therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to 30 Apr 2018
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of panic disorder
- at least moderate agoraphobic avoidance
Who cannot join
- psychoactive medication last 6 weeks
- exposure-based cognitive-behaviour treatment for panic disorder and agoraphobia during last 3 months
- female participant who is pregnant or breast-feeding
- lifetime history of psychosis, bipolar disorder, alcohol, medication or drug abuse or dependence; current primary depressive disorder
- lifetime history of epilepsy or other significant disease or disorder
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Psychiatry, University of Oxford
Oxford, OX37JX
About this study
Official title: The Effect of a Single-dose of D-cycloserine on the Basic Effects of Cognitive-behaviour Therapy for Panic Disorder - a Randomized Placebo-controlled Trial
The purpose of this study is to determine whether d-cycloserine augments the clinical effects of exposure-based cognitive-behaviour therapy for panic disorder.
- Conditions
- Panic Disorder
- Being tested
- d-cycloserine, placebo, cognitive-behaviour therapy
- Keywords
- d-cycloserine, cognitive-behaviour therapy, panic disorder
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-cycloserineDrug
placeboDrug
cognitive-behaviour therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| d-cycloserine | Experimental | oral, capsule, 250 mg, once Receives: Drug: d-cycloserine; Behavioral: cognitive-behaviour therapy |
| sugar pill | Placebo comparator | oral, capsule, once Receives: Drug: placebo; Behavioral: cognitive-behaviour therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported and clinician-rated anxiety and depression measures
Measured: 6 months
Secondary outcomes (1)
emotional information processing
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startOct 2012
- Primary completion31 Oct 2017
- Study completion30 Apr 2018
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.
- More trials run by University of OxfordThe 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Andrea Reinecke, PhD, Principal investigator, University of OxfordCatherine Harmer, PhD, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680107
- Sponsor's protocol ID
- MRC-01
- Other IDs
- 2012-003191-39
- Status last verified
- May 2018
- First submitted
- 3 Sep 2012
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reinecke A, Nickless A, Browning M, Harmer CJ. Neurocognitive processes in d-cycloserine augmented single-session exposure therapy for anxiety: A randomized placebo-controlled trial. Behav Res Ther. 2020 Jun;129:103607. doi: 10.1016/j.brat.2020.103607. Epub 2020 Mar 19.
PubMed 32229324
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single-dose of D-cycloserine on the Basic Effects of Cognitive-behaviour Therapy for Panic Disorder - a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01680107
- Acronym / sponsor ID
- MRC-01
- Conditions
- Panic Disorder
- Keywords
- d-cycloserine, cognitive-behaviour therapy, panic disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Oct 2012
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 6 Sep 2012 (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 d-cycloserine augments the clinical effects of exposure-based cognitive-behaviour therapy for panic disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| d-cycloserine | Experimental | Drug: d-cycloserine, Behavioral: cognitive-behaviour therapyoral, capsule, 250 mg, once |
| sugar pill | Placebo comparator | Drug: placebo, Behavioral: cognitive-behaviour therapyoral, capsule, once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of panic disorder
- at least moderate agoraphobic avoidance
Key exclusion criteria (5 listed)
- psychoactive medication last 6 weeks
- exposure-based cognitive-behaviour treatment for panic disorder and agoraphobia during last 3 months
- female participant who is pregnant or breast-feeding
- lifetime history of psychosis, bipolar disorder, alcohol, medication or drug abuse or dependence; current primary depressive disorder
- lifetime history of epilepsy or other significant disease or disorder
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 |
|---|---|---|
| d-cycloserine | Drug | d-cycloserine |
| placebo | Drug | sugar pill |
| cognitive-behaviour therapy | Behavioural | d-cycloserine, sugar pill |
Primary outcome
self-reported and clinician-rated anxiety and depression measures
Time frame: 6 months
1 secondary outcome
emotional information processing
Time frame: 1 day
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 32229324Reinecke A, Nickless A, Browning M, Harmer CJ. Neurocognitive processes in d-cycloserine augmented single-session exposure therapy for anxiety: A randomized placebo-controlled trial. Behav Res Ther. 2020 Jun;129:103607. doi: 10.1016/j.brat.2020.103607. Epub 2020 Mar 19.
Related trials for Panic Disorder
Not yet recruiting
A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder
Panic Disorder, Agoraphobia
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Active, not recruiting
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood
Recruiting
Qigong and Multicomponent Exercise in Panic Disorder
Panic Disorder, Panic Disorder (With or Without Agoraphobia)
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
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.
Andrea Reinecke, PhD principal investigator
University of Oxford
Catherine Harmer, PhD study director
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing d-cycloserine and cognitive-behaviour therapy in people with Panic Disorder, run by University of Oxford at 1 site in United Kingdom.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 3 May 2018. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
self-reported and clinician-rated anxiety and depression measures (time frame: 6 months). 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 NCT01680107, 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 3 May 2018.