Sertraline in post Stroke Depression in Irkutsk, Russia

ISRCTN	ISRCTN60046672
DOI	https://doi.org/10.1186/ISRCTN60046672
Secondary identifying numbers	N/A

Submission date: 27/02/2012
Registration date: 30/03/2012
Last edited: 18/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The current treatment of stroke focuses on early diagnosis and early use of medication that improves the disease. However, a major proportion of patients has remaining disability and still needs rehabilitation. Depression after ischemic stroke is one of the major problems complicating the rehabilitation. A major challenge is therefore to help patients maintain self-management strategies introduced in the rehabilitation period, and thereby enhance a longer lasting effect of rehabilitation.
Goal planning or goal setting is considered an important part of stimulation techniques in rehabilitation. Several studies show that goal planning can influence patients' adherence to treatment regimes and improve immediate patient performance, but evidence regarding how it may improve results after rehabilitation programs is inconsistent. Rehabilitation goals often address motor recovery not mental and behavioral elements. A new and potentially more effective rehabilitation program has been developed. The main aim of this study is to measure the usefulness of this new rehabilitation program compared to the current traditional rehabilitation programs. The expected usefulness of the new program will be expressed in terms of goal attainment and health benefits for participating patients, and with regard to if it helps with the recovery process.

Who can participate?
Patients who are admitted to the clinic of nervous diseases with cerebral ischemic stroke.

What does the study involve?
Participants will be randomly allocated to one of two groups. While one group will receive traditional rehabilitation, the other group will also receive the new SeStDe program.

What are the possible benefits and risks of participating?
All participants will receive rehabilitation which may improve their health and physical function. There are no known risks to participants.

Where is the study run from?
The study takes place at the clinic of nervous diseases of Irkutsk State Medical University (Russia).

When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study between August 2010 and August 2012. Follow-up examinations will continue until August 2013.

Who is funding the study?
Irkutsk State Medical University (Russia).

Who is the main contact?
Dr Yury Bykov
bykov1971@mail.ru

Contact information

Prof Yury Bykov
Scientific

Krasnogo Vosstania, 1
Irkutsk
664003
Russian Federation

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised controlled study in patients with ischemic stroke treated with antidepressant sertraline (Stimuloton) and rhythmic stimulation in Irkutsk, Russia
Study acronym	SeStDe
Study objectives	Effectiveness rehabilitation in patients with cerebral ischemic stroke remains one of the most actual problems in neurology. A depression following an ischemic stroke is one of the major problems complicating the rehabilitation. We suggest effectiveness of treatment including traditional therapy, the antidepressant sertraline (Stimuloton), and external rhythmic stimulation in the rehabilitation of patients with post-stroke depression.
Ethics approval(s)	Irkutsk State Medical University, 12/12/2006
Health condition(s) or problem(s) studied	Rehabilitation after stroke
Intervention	1. 30 depressive patients were treated by standard treatment 2. 31 patients received this standard treatment with additional rhythmic stimulation - rhythmic stimulation was presented by light and sound stimulation in individual regimes with hand tapping on keyboard of PC. There are seven regimes of stimulation: 1. Individual spontaneous rhythm, prescribing frequency of stimulus in following regimes 2. Sound stimulation with contemporary hands tapping 3. Sound stimulation with delayed tapping after sound stimulus 4. Light stimulation with contemporary tapping 5. Light stimulation with delayed tapping after light stimulus 6. Light-sound stimulation with contemporary tapping 7. Light-sound stimulation with delayed tapping after light-sound stimulus Every day stimulation will be prescribed for stroke patients. Duration of intervention: 20-21 days. All patients were assessed twice: 1 day (before treatment), 20-21 day (after beginning of prescribed treatment). Catamnesis of patients including this investigation were carried out in 6-12 months. 3. 15 of them received rhythmic stimulation and sertraline (Stimuloton), 100 mg/day 4. 60 patients had no depressive symptoms
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sertraline (Stimuloton)
Primary outcome measure	1. Lindmark Scale (LI) 2. The Hamilton Depression Rating Scale (HDRS) 3. The Hospital Anxiety Depression Scale 4. SF-36 Assessed on day of admittance of patients and on day 20 or 21 of treatment
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/09/2006
Completion date	01/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	121
Key inclusion criteria	1. Patients after ischemic stroke 2. No seizures
Key exclusion criteria	1. Patients with sever cognitive impairments 2. Epileptic seizures
Date of first enrolment	01/09/2006
Date of final enrolment	01/03/2012

Locations

Countries of recruitment

Russian Federation

Study participating centre

Krasnogo Vosstania, 1

Irkutsk
664003
Russian Federation

Sponsor information

Irkutsk State Medical University (Russia)
Hospital/treatment centre

Krasnogo Vosstania, 1
Irkutsk
664003
Russian Federation

Website	http://ismu.baikal.ru
"ROR"	https://ror.org/05qwrn075

Funders

Funder type

Hospital/treatment centre

Irkutsk State Medical University (Russia)

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