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The effect of adding pregabalin to antipsychotics on positive and negative symptoms in patients with schizophrenia: A randomized placebo-controlled double blind trial

Protocol summary

Summary
Schizophrenia is a devastating clinical syndrome which deeply affects cognition, emotion, perception and the other aspects of behavior. Antipsychotic agents are not effective in all patients just as on all symptoms of disorder. About 10-20% of schizophrenic patients do not benefit from neuroleptic agents except in small amounts. Therefore, new therapeutic strategies such as neuroleptic combination with anti-epileptic agents have been used to treat the disease. In some cases, prescribing Pregabalin has been reduced anxiety and positive and negative symptoms of schizophrenia. The aim of this study is to investigate the effect of Pregabalin on positive and negative symptoms of refractory schizophrenia. This is a prospective, randomized, double-blind, placebo-controlled study done within 6 weeks. 48 patients were randomly divided into two groups receiving drug and placebo. PANSS, AIMS and Czech list of side effects will be recorded at baseline, week 3 and week 6, by an assistant psychiatry. Pregabalin starts at the doses of 75mg and after three weeks, the dose will be 150 mg. Administration of placebo and increasing the dosage, will be in accordance with Pregabalin. After 6 weeks the data is collected.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092711885N7
Registration date: 2017-01-03, 1395/10/14
Registration timing: na

Last update:
Update count: 0
Registration date
2017-01-03, 1395/10/14
Registrant information
Name
Samaneh Farnia
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 5659
Email address
sfarnia@mazums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2017-02-03, 1395/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding pregabalin to antipsychotics on positive and negative symptoms in patients with schizophrenia: A randomized placebo-controlled double blind trial
Public title
The effect of pregabalin in the treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Diagnosis of schizophrenia according to DSM-V criteria by psychiatrist 2. Age 18 to 65 years 3. Informed consent / guardian for inclusion 4. Treatment with antipsychotics 5. Refractory schizophrenia Exclusion criteria: 1. Other psychiatric disorders axis I or II exist 2. Serious or chronic diseases like renal and liver dysfunction, severe diarrhea, cardiovascular disease, urinary tract infection, head injury 3. Pregnancy 4. Breastfeeding 5. Lack of appropriate contraception in women of reproductive age 6. Substance abuse over the past month 7. Intolerable side effects 8. History of allergy to Pregabalin 9. Change the doses of antipsychotic agents during last two weeks 10. Patient/ guardian’s apply to withdraw from the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciencesnces
Street address
moallem Sq
City
sari
Postal code
Approval date
2016-12-18, 1395/09/28
Ethics committee reference number
IR.MAZUMS.REC.95.1809

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
schizophrenia

Primary outcomes

1

Description
Positive and negative symptom of schizophrenia
Timepoint
Before intervention, three weeks after beginning intervention, the end of intervention
Method of measurement
Positive_and_Negative_Syndrome_Scale

Secondary outcomes

1

Description
Extra pyramidal syndrome
Timepoint
Before intervention, three weeks after beginning intervention, the end of intervention
Method of measurement
Abnormal-Involuntary-Movement-Scale

Intervention groups

1

Description
twenty-four patients receive pregabalin capsule75 mg/ daily up to 3weeks , then twice a day for 3 weeks next
Category
Treatment - Drugs

2

Description
24 patients receive Placebo capsule daily up to 3weeks then twice a day for next 3weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
zare hospital
Full name of responsible person
Dr.samane farnia
Street address
Neka road
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Moallem Square
City
sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Medical science of mazandaran university
Full name of responsible person
Elham mahtiyan
Position
Psychiatrist Assistant
Other areas of specialty/work
Street address
Zare hospital,neka road
City
Sari
Postal code
Phone
+98 11 3328 3886
Fax
Email
E_mahtiyan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
mazandaran university of medical science
Full name of responsible person
Dr samane farnia
Position
Assistant professor
Other areas of specialty/work
Street address
start of valieasr highway,Imam Sq
City
Sari
Postal code
Phone
+98 11 3328 5659
Fax
Email
Sm.farnia@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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