Effect of paroxetine treatment on glycaemic control and quality of life in mildly depressed type two diabetic subjects: a double-blind randomised placebo controlled six month trial
ISRCTN | ISRCTN55819922 |
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DOI | https://doi.org/10.1186/ISRCTN55819922 |
Secondary identifying numbers | N/A |
- Submission date
- 02/08/2006
- Registration date
- 13/09/2006
- Last edited
- 26/06/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kristian Wahlbeck
Scientific
Scientific
Psychiatric unit
Vaasa Central Hospital
Vaasa
FIN-65130
Finland
kristian.wahlbeck@stakes.fi |
Study information
Study design | Randomised double-blind placebo-controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | We hypothesised that paroxetine will have a beneficial effect on quality of life and on glycaemic control in mildly depressed diabetics. |
Ethics approval(s) | Helsinki University Central Hospital ethics review committee has approved the study in 2001 |
Health condition(s) or problem(s) studied | Type two diabetes mellitus and depression. |
Intervention | Paroxetin 20 mg per day or placebo for six months. Blood samples and clinical examination four times during the trial. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Paroxetine |
Primary outcome measure | 10% decrease in HbA1c. |
Secondary outcome measures | 20% improvement in quality of life as defined by the RAND-36 health relate quality of life questionnaire. |
Overall study start date | 01/06/2001 |
Completion date | 20/12/2002 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 38 |
Key inclusion criteria | 1. Volunteers between 50 and 70 years of age 2. Diagnosed type two diabetes 3. Hba1c more than 7.0% 4. Mild symptoms of depression |
Key exclusion criteria | 1. Moderate to severe depression based on Diagnostic and Statistical Manual of mental disorders (DSM-IV) criteria 2. Severe diabetic complications 3. Use of warfarin 4. Glaucoma |
Date of first enrolment | 01/06/2001 |
Date of final enrolment | 20/12/2002 |
Locations
Countries of recruitment
- Finland
Study participating centre
Psychiatric unit
Vaasa
FIN-65130
Finland
FIN-65130
Finland
Sponsor information
GlaxoSmithKline (Finland)
Industry
Industry
Piispansilta 9 A
3 krs.
Espoo
Helsinki
02230
Finland
terese.m.pfister-peltola@sb.com | |
https://ror.org/01jxkq910 |
Funders
Funder type
Industry
Funded by GlaxoSmithKline
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | Results: | 15/06/2007 | Yes | No |