Panic DisorderPhase 4ExparoxNCT00540098
Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder
A Phase 4 study testing paroxetine + aerobic exercise and Paroxetine + relaxation in people with Panic Disorder, run by University of Göttingen at 1 site in Germany.
Trial summary
Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination with regular aerobic exercise (running) or regular relaxation training in the treatment of panic disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- paroxetine + aerobic exercise and Paroxetine + relaxation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2001to Jun 2005
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Panic disorder with or without agoraphobia due to DSM-IV
- Written informed consent
- Score of 17 or more on the P\&A scale
- Score on the CGI of 4 or more (markedly ill)
Who cannot join
- Pregnancy, lactating or insufficient contraception (pearl index >1)
- Other psychiatric disorders such as psychoses, addictive disorders, dementia, etc.
- Clinically relevant abnormalities in physical examination or laboratory results
- Prior major depression or bipolar disorder
- Suicidality
- psychotropic medication other than promethazine
- current psychological treatment
- unable to perform regular aerobic exercise
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Göttingen, Dept of Psychiatry and Psychotherapy
Göttingen, 37075
About this study
Official title: A Randomized, Controlled Trial on the Effects of Paroxetine Versus Placebo in Combination With Aerobic Exercise or Relaxation Training in the Treatment of Panic Disorder
Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination with regular aerobic exercise (running) or regular relaxation training in the treatment of panic disorder.
Read the detailed description
In continuation of prior work from our group (Broocks A, Bandelow B, Pekrun G, et al. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry 1998; 155(5):603-9.) it is the purpose of this trial to test the assumed superiority of a combined therapy of paroxetine and aerobic exercise compared to placebo or unspecific relaxation training in panic disorder. Participants were randomized to a 10 week treatment protocol of paroxetine 40 mg daily or placebo in combination with regular exercise or regular relaxation after having given informed consent and screening of in- and exclusion criteria.
- Conditions
- Panic Disorder
- Being tested
- paroxetine + aerobic exercise, Paroxetine + relaxation, Placebo + aerobic exercise, Placebo + relaxation
- Keywords
- panic disorder, pharmacotherapy, non-pharmacological treatment, SSRI, paroxetine, exercise
- Medical subject headings
- Panic Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paroxetine + aerobic exerciseDrug
paroxetine, 40 mg once daily + regular aerobic exercise
Paroxetine + relaxationDrug
paroxetine, 40 mg once daily + regular relaxation training
Placebo + aerobic exerciseDrug
placebo pill once daily + regular aerobic exercise
Placebo + relaxationDrug
placebo pill once daily + regular relaxation training
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Paroxetine + aerobic exercise Receives: Drug: paroxetine + aerobic exercise |
| 2 | Active comparator | Paroxetine + relaxation Receives: Drug: Paroxetine + relaxation |
| 3 | Active comparator | Placebo + aerobic exercise Receives: Drug: Placebo + aerobic exercise |
| 4 | Placebo comparator | Placebo + relaxation Receives: Drug: Placebo + relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
Measured: Baseline to endpoint (10 weeks)
Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)
Measured: Baseline to endpoint (10 weeks)
Secondary outcomes (3)
Symptom severity due to Hamilton Anxiety Scale (HAMA)
Measured: Baseline to endpoint (10 weeks)
Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)
Measured: Baseline to endpoint (10 weeks)
Response and remission analysis between groups
Measured: LOCF-analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startSep 2001
- Study completionJun 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Borwin Bandelow, Prof, MD, Principal investigator, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540098
- Sponsor's protocol ID
- 290060/552
- Acronym
- Exparox
- Status last verified
- Oct 2007
- First submitted
- 3 Oct 2007
- Last updated
- 5 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Broocks A, Bandelow B, Pekrun G, George A, Meyer T, Bartmann U, Hillmer-Vogel U, Ruther E. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry. 1998 May;155(5):603-9. doi: 10.1176/ajp.155.5.603.
PubMed 9585709
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial on the Effects of Paroxetine Versus Placebo in Combination With Aerobic Exercise or Relaxation Training in the Treatment of Panic Disorder
- ClinicalTrials.gov ID
- NCT00540098
- Acronym / sponsor ID
- Exparox / 290060/552
- Conditions
- Panic Disorder
- Keywords
- panic disorder, pharmacotherapy, non-pharmacological treatment, SSRI, paroxetine, exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2001
- Study completion
- Jun 2005 (actual)
- First posted
- 5 Oct 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.
Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination with regular aerobic exercise (running) or regular relaxation training in the treatment of panic disorder.
Detailed description
In continuation of prior work from our group (Broocks A, Bandelow B, Pekrun G, et al. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry 1998; 155(5):603-9.) it is the purpose of this trial to test the assumed superiority of a combined therapy of paroxetine and aerobic exercise compared to placebo or unspecific relaxation training in panic disorder. Participants were randomized to a 10 week treatment protocol of paroxetine 40 mg daily or placebo in combination with regular exercise or regular relaxation after having given informed consent and screening of in- and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: paroxetine + aerobic exerciseParoxetine + aerobic exercise |
| 2 | Active comparator | Drug: Paroxetine + relaxationParoxetine + relaxation |
| 3 | Active comparator | Drug: Placebo + aerobic exercisePlacebo + aerobic exercise |
| 4 | Placebo comparator | Drug: Placebo + relaxationPlacebo + relaxation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Panic disorder with or without agoraphobia due to DSM-IV
- Written informed consent
- Score of 17 or more on the P\&A scale
- Score on the CGI of 4 or more (markedly ill)
Key exclusion criteria (8 listed)
- Pregnancy, lactating or insufficient contraception (pearl index >1)
- Other psychiatric disorders such as psychoses, addictive disorders, dementia, etc.
- Clinically relevant abnormalities in physical examination or laboratory results
- Prior major depression or bipolar disorder
- Suicidality
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 |
|---|---|---|
| paroxetine + aerobic exerciseparoxetine, 40 mg once daily + regular aerobic exercise | Drug | 1 |
| Paroxetine + relaxationparoxetine, 40 mg once daily + regular relaxation training | Drug | 2 |
| Placebo + aerobic exerciseplacebo pill once daily + regular aerobic exercise | Drug | 3 |
| Placebo + relaxationplacebo pill once daily + regular relaxation training | Drug | 4 |
Primary outcome
Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
Time frame: Baseline to endpoint (10 weeks)
Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)
Time frame: Baseline to endpoint (10 weeks)
3 secondary outcomes
Symptom severity due to Hamilton Anxiety Scale (HAMA)
Time frame: Baseline to endpoint (10 weeks)
Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)
Time frame: Baseline to endpoint (10 weeks)
Response and remission analysis between groups
Time frame: LOCF-analysis
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 5 Oct 2007.
- Background: PubMed 9585709Broocks A, Bandelow B, Pekrun G, George A, Meyer T, Bartmann U, Hillmer-Vogel U, Ruther E. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry. 1998 May;155(5):603-9. doi: 10.1176/ajp.155.5.603.
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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.
Borwin Bandelow, Prof, MD principal investigator
University of Göttingen
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 paroxetine + aerobic exercise and Paroxetine + relaxation in people with Panic Disorder, run by University of Göttingen at 1 site in Germany.
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 4 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 5 Oct 2007. 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 Germany. 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 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?
Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A) (time frame: Baseline to endpoint (10 weeks)). The study lists 2 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 NCT00540098, 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 5 Oct 2007.