Phobic DisordersPhase 4NCT00184106
RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo
A Phase 4 study testing Seroxat, Cognitive therapy, Seroxat+ cognitive therapy in people with Phobic Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their combination, (2) investigate the patterns of change and the mechanisms of action involved during treatment by using psycho-physiological assessments in order to delineate some of the cognitive, behavioural and physiological… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phobic Disorders
- What is being tested?
- Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2004to Dec 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent obtained prior to entry in the study.
- Diagnosed with primary social phobia, generalized or specific (DSM-IV, APA, 1994).
- Symptoms present at least one year.
- Age between 18-65 years.
Who cannot join
- Known somatic diseases.
- Pregnant (*) or lactating women.
- Psychosis
- Acute suicidal symptoms
- Major depressive disorder
- Generalized Anxiety Disorder or PTSD
Show all 12Show fewer
- Cluster A or cluster B personality disorder
- Substance abuse or dependence
- Body dysmorphic disorder.
- Not willing to accept random allocation.
- Patients who take some form of SSRI medications currently or during the last 6 months
- Patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial or are taking herbal remedies that may be hazardous or inflict treatment response.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Triple Blind, Placebo-controlled Trial Comparing the Effects of Cognitive Therapy, Paroxetine and Both Cognitive Therapy and Paroxetine in the Treatment of Patients With Primary Social Phobia
We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their combination, (2) investigate the patterns of change and the mechanisms of action involved during treatment by using psycho-physiological assessments in order to delineate some of the cognitive, behavioural and physiological mechanisms in the patients' response to CT, to paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be selected and randomised into four treatment conditions. The first group (N=25) will be treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo and clinical management (N=25). All patients will have 12 weeks of treatment in the acute phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The 4th group will have placebo for 24 weeks and clinical management. The patients will be assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12 weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months.
Measures are based on all three main sources; self-report inventories, clinical assessments by independent raters and psycho-physiological assessments.
- Conditions
- Phobic Disorders
- Being tested
- Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
- Keywords
- Phobic disorders, Therapy, cognitive, Paroxetine
- Medical subject headings
- Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seroxat, Cognitive therapy, Seroxat+ cognitive therapyDrug
Also called Paroxetine
Seroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy | Active comparator | Cognitive Therapy Receives: Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy |
| Seroxat and SE | Active comparator | SSRI with Self exposure Receives: Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy |
| Seroxat and Cognitive Therapy | Active comparator | Combination of Seroxat and Cognitive Therapy Receives: Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy |
| Pill-Placebo | Placebo comparator | Pill Placebo Receives: Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week.
Measured: December 2010
A patient is classified as responder if the decrease on FNE is equivalent with or above 40%.
Measured: December 2010
Secondary outcomes (1)
Relapse rate during 6 and 12 months of follow up.
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Phobic DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Hans M Nordahl, Professor, Principal investigator, Norwegian University of Science and Technology, NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184106
- Sponsor's protocol ID
- SP/NTNU-2005
- Status last verified
- Aug 2018
- First submitted
- 9 Sep 2005
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nordahl HM, Vogel PA, Morken G, Stiles TC, Sandvik P, Wells A. Paroxetine, Cognitive Therapy or Their Combination in the Treatment of Social Anxiety Disorder with and without Avoidant Personality Disorder: A Randomized Clinical Trial. Psychother Psychosom. 2016;85(6):346-356. doi: 10.1159/000447013. Epub 2016 Oct 15.
PubMed 27744447Nordahl H, Nordahl HM, Hjemdal O, Wells A. Cognitive and metacognitive predictors of symptom improvement following treatment for social anxiety disorder: A secondary analysis from a randomized controlled trial. Clin Psychol Psychother. 2017 Nov;24(6):1221-1227. doi: 10.1002/cpp.2083. Epub 2017 Mar 15.
PubMed 28295802
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Triple Blind, Placebo-controlled Trial Comparing the Effects of Cognitive Therapy, Paroxetine and Both Cognitive Therapy and Paroxetine in the Treatment of Patients With Primary Social Phobia
- ClinicalTrials.gov ID
- NCT00184106
- Acronym / sponsor ID
- SP/NTNU-2005
- Conditions
- Phobic Disorders
- Keywords
- Phobic disorders, Therapy, cognitive, Paroxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Oct 2004 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Sep 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.
We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their combination, (2) investigate the patterns of change and the mechanisms of action involved during treatment by using psycho-physiological assessments in order to delineate some of the cognitive, behavioural and physiological mechanisms in the patients' response to CT, to paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be selected and randomised into four treatment conditions. The first group (N=25) will be treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo and clinical management (N=25). All patients will have 12 weeks of treatment in the acute phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The 4th group will have placebo for 24 weeks and clinical management. The patients will be assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12 weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months.
Measures are based on all three main sources; self-report inventories, clinical assessments by independent raters and psycho-physiological assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy | Active comparator | Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapyCognitive Therapy |
| Seroxat and SE | Active comparator | Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapySSRI with Self exposure |
| Seroxat and Cognitive Therapy | Active comparator | Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapyCombination of Seroxat and Cognitive Therapy |
| Pill-Placebo | Placebo comparator | Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapyPill Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent obtained prior to entry in the study.
- Diagnosed with primary social phobia, generalized or specific (DSM-IV, APA, 1994).
- Symptoms present at least one year.
- Age between 18-65 years.
Key exclusion criteria (12 listed)
- Known somatic diseases.
- Pregnant (*) or lactating women.
- Psychosis
- Acute suicidal symptoms
- Major depressive 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 |
|---|---|---|
| Seroxat, Cognitive therapy, Seroxat+ cognitive therapyAlso: ParoxetineSeroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up | Drug | Cognitive Therapy, Pill-Placebo, Seroxat and Cognitive Therapy, Seroxat and SE |
Primary outcome
The proportion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week.
Time frame: December 2010
A patient is classified as responder if the decrease on FNE is equivalent with or above 40%.
Time frame: December 2010
1 secondary outcome
Relapse rate during 6 and 12 months of follow up.
Time frame: December 2010
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 27 Aug 2018.
- Results publication: PubMed 27744447Nordahl HM, Vogel PA, Morken G, Stiles TC, Sandvik P, Wells A. Paroxetine, Cognitive Therapy or Their Combination in the Treatment of Social Anxiety Disorder with and without Avoidant Personality Disorder: A Randomized Clinical Trial. Psychother Psychosom. 2016;85(6):346-356. doi: 10.1159/000447013. Epub 2016 Oct 15.
- Results publication: PubMed 28295802Nordahl H, Nordahl HM, Hjemdal O, Wells A. Cognitive and metacognitive predictors of symptom improvement following treatment for social anxiety disorder: A secondary analysis from a randomized controlled trial. Clin Psychol Psychother. 2017 Nov;24(6):1221-1227. doi: 10.1002/cpp.2083. Epub 2017 Mar 15.
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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.
Hans M Nordahl, Professor principal investigator
Norwegian University of Science and Technology, NTNU
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 Seroxat, Cognitive therapy, Seroxat+ cognitive therapy in people with Phobic Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
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 12 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 27 Aug 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 Norway. 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?
The proportion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week. (time frame: December 2010). 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 NCT00184106, which also lists 2 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 27 Aug 2018.