Exploratory trial of antidepressant therapy for dizziness
| ISRCTN | ISRCTN80847419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80847419 |
| Protocol serial number | N0530147182 |
| Sponsor | Department of Health |
| Funder | North Central London Research Consortium (UK) NHS support funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 20/09/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
| Phone | +44 (0)20 7830 2394 |
|---|---|
| I.nazareth@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | In primary care attendees with symptoms of dizziness and associated psychological symptoms, a) antidepressants and b) vestibular rehabilitation exercises reduces symptoms of dizziness when either treatment is delivered singly or together in a factional design. Prior to testing this hypothesis, in this study the researchers propose to conduct an exploratory trial in which they will examine the effects of varying doses of antidepressants, on the symptoms of dizziness amongst general practice attendees visiting their GP for this purpose. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Dizziness |
| Intervention | 1. Low dose antidepressant (Citalopram) therapy and self-help leaflet 2. Full dose antidepressant (Citalopram) and self-help leaflet 3. A control group receiving no antidepressant treatment, but receiving self-help leaflet Added 20/09/2013: this trial never took place as there was no sponsorship agreed. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Citalopram |
| Primary outcome measure(s) |
The community prevalence of dizziness ranges from 16-35%. One quarter of such sufferers report chronic handicapping symptoms and psychological distress. There are currently no evaluations of treatment for dizziness in the community. This study is the first step in evaluating a treatment that has been previously examined in a hospital setting. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2005 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 64 |
| Key inclusion criteria | GP attendees with acute symptoms of dizziness, vertigo, lightheadedness, dysequilibrium, presyncope, and other types of balance problems for more than 2 months, associated with associated psychological symptoms. |
| Key exclusion criteria | 1. Below 18 years old and above 85 years old 2. Too ill to take part (i.e serious physical illness or terminal disorder) 3. First episode of dizziness 4. Acute dizziness 5. Vetebrobasilar insufficiency 6. Cardivascular diagnoses 7. Severe neurological disorders |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 31/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
NW3 2PF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
