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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Kristian Wahlbeck
Scientific

Psychiatric unit
Vaasa Central Hospital
Vaasa
FIN-65130
Finland

Email	kristian.wahlbeck@stakes.fi

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Paroxetine
Primary outcome measure(s)	10% decrease in HbA1c.
Key secondary outcome measure(s)	20% improvement in quality of life as defined by the RAND-36 health relate quality of life questionnaire.
Completion date	20/12/2002

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Psychiatric unit

Vaasa
FIN-65130
Finland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	15/06/2007		Yes	No