The prediction of short-term and long-term treatment response to sertraline in panic disorder
| ISRCTN | ISRCTN03447252 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03447252 |
| Protocol serial number | STL-NL-96-002 |
| Sponsor | University Medical Center Groningen (The Netherlands) |
| Funder | Pfizer |
- Submission date
- 22/11/2006
- Registration date
- 22/11/2006
- Last edited
- 04/12/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr P P Mersch
Scientific
Scientific
University Medical Center Groningen
Department of Psychiatry
P.O. Box 30001
Rotterdam
9700 RB
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Baseline variables such as harm avoidance and other personality, biological and electrophysiological measures will predict treatment outcome to an Selective Serotonin Reuptake Inhibitor (SSRI). |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Panic disorder |
| Intervention | Intervention: Treatment with Sertraline (50 mg) for a period of 57 weeks Investigators Assessments: Hamilton Anxiety Scale Hamilton Depression Scale Clinical Global Impression Subjects assessments: Frequency of panic attacks Fear Questionnaire Patient Global Evaluation Symptoms CheckList (SCL-90) Temperament and Character Inventory NEO-Neuroticism subscale Rand 36-item health survey Rosenberg Self-esteem list Biochemical assessments: Plasma 3-Methoxy-4-HydroxyPhenylGlycol (MHPG) level Plasma Sertraline level Electrophysiology: Heart Rate Variability |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sertraline |
| Primary outcome measure(s) |
To identify variables mentioned above (at baseline) that can predict short-term and long-term response to treatment with sertraline in Panic Disorder. |
| Key secondary outcome measure(s) |
1. To establish whether Autonomous Nervous System (ANS) functioning is a state marker of illness severity. |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | |
| Target sample size at registration | 57 |
| Key inclusion criteria | 1. Panic Disorder According to Diagnostic and Statistical Manual of mental disorders (DSM-IV) 2. Two panic attacks in medication-free run-in period 3. Outpatients more than 18 years |
| Key exclusion criteria | 1. Co-morbid psychotic disorder, alcohol abuse, major affective disorder or personality disorder in the last year 2. Participation in other drug trial 30 days prior to selection 3. Serious medical illness 4. History of hepatitis 5. Risk of suicidality 6. History of drug allergy of hypersensitivity to SSRIs 7. Pregnancy, lactation or childbearing potential during the study |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Rotterdam
9700 RB
Netherlands
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
