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IRCT20210531051453N1 IRCT 2021-07-30 University of social welfare and rehabilitation sciences Effect of omega 3 fatty acid in borderline personality disorder Study the effectiveness of omega 3 fatty acid as adjuvant treatment on depression, aggression and poor impuls control in hospitalized patients of borderline personality disorder 2021-08-01 anticipated 23 Complete https://irct.ir/trial/56591 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to fix some possible tours in this study, simple coincidence will be observed. In this study, to randomly allocate people to two groups, first using software under the web https://www.Randomization.com a random sequence of number will be created. Also cases such as the person who will create sequence, the person who will check the participants in terms of entry and exit criteria and enroll them in the study, and the person who will assign the participants to the groups are separated from each other, Blinding description: The design of this study will take place in terms of blindness. This type of design is so that the people studied are not aware of the type of study and the evaluation is not aware of the intervention in every patient. The purpose of this type of design is to prevent the appearance of the observers net. This tour means that the results observed from the plane are affected by the attitude and behavior of the patient or doctor. So the design of this study will be done in a way to minimize possible nets and results closer to reality. 3 Borderline personality disorder. Intervention 1: "Intervention group": Olanzapine is an atypic antipsychotic drug with C17H20N4S chemical formulation and tino benzodiazepine derivatives with half life of 21 to 54 hours and has liver metabolism that can inhibit the attraction of serotonin and dopamine at the end of presynapsis nervous system that can reduce aggression and to get better mood. This drug will be used with the dose of 5 to 15 mg per day according to the patient's response for 6 weeks and the drug used by Abidi pharmaceutical company, Omega 3 drug is a long chain fatty acid means an 18 carbonic chain with 3 double transplant on 9, 12 and 15' s carbons. That according to the hypothesis of reducing Omega 3 fatty acids in the membrane of neurons of borderline personality disorder, this drug will be used with the dose of 2 grams a day for 6 week and the drug used by Actover pharmaceutical company. Currently, the only approved treatment for borderline personality disorder is psychotherapy and this treatment is now the most effective treatment for this disorder.Therapists use behavioral therapy to control patient's momentum and anger explosions and to reduce their sensitivity to criticism and expulsion, and through social skills training, the patient is helped to see the impact of their actions on other an their inter individual behavior. Improve Dialectical Behavioral Therapy (DBT),which is the most common type of psychotherapy used in this patient is especially used in patient who have attempted suicide or self esteem and give better control of momentum in patients for 4 weeks and every week for one hour in the psycotherapic clinic in Razi Psychiatric hospital will be performed by final year Psychiatric resident. Intervention 2: "Control group:" Olanzapine is an atypic antipsychotic drug that can reduce aggression and to get better mood by impact on serotonin and dopamin. This drug will be used with the dose of 5 to 15 mg per day according to the patient's response for 6 weeks and the drug used by Abidi pharmaceutical company, According that the only approved treatment for borderline personality disorder is psychotherapy, Dialectical Behavioral Therapy (DBT), the most common type of psychotherapy will be used in theses patients for 4 weeks and every week for one hour in the psycotherapic clinic in Razi Psychiatric hospital will be performed by final year Psychiatric resident. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Ensieh Sadri
No 17, South Ebrahimi Ave, East Ferdos Blvd, Tehran
Tehran Iran (Islamic Republic of) 1481958465 +98 21 4405 7355 Sadri.ensieh@gmail.com University of social welfare and rehabilitation sciences scientific Ensieh Sadri
No 17,South Ebrahimi Ave, East Ferdos Blvd, Tehran
Tehran Iran (Islamic Republic of) 1481958465 +98 21 4405 7355 Sadri.ensieh@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Definitive diagnosis of borderline personality disorder based on DSM V Age range between 18 till 60 years old Disorder leads to referral for treatment and hospitalization IQ is higher than 70 Patient and patients price have conscious consent to participate in the study 18 years 60 years Both Having psychological disorders except substance abuse disorder Having diabetes, metabolic disorders, serious medical or nourological diseases Having extrapyramidal symptoms such as hands tremor, mouth watering, neck dystonia, rigidity and akathisia Pregnancy and breastfeeding F60.3 Borderline personality disorder Treatment - Drugs Treatment - Drugs "Intervention group": Olanzapine is an atypic antipsychotic drug with C17H20N4S chemical formulation and tino benzodiazepine derivatives with half life of 21 to 54 hours and has liver metabolism that can inhibit the attraction of serotonin and dopamine at the end of presynapsis nervous system that can reduce aggression and to get better mood. This drug will be used with the dose of 5 to 15 mg per day according to the patient's response for 6 weeks and the drug used by Abidi pharmaceutical company, Omega 3 drug is a long chain fatty acid means an 18 carbonic chain with 3 double transplant on 9, 12 and 15' s carbons. That according to the hypothesis of reducing Omega 3 fatty acids in the membrane of neurons of borderline personality disorder, this drug will be used with the dose of 2 grams a day for 6 week and the drug used by Actover pharmaceutical company. Currently, the only approved treatment for borderline personality disorder is psychotherapy and this treatment is now the most effective treatment for this disorder.Therapists use behavioral therapy to control patient's momentum and anger explosions and to reduce their sensitivity to criticism and expulsion, and through social skills training, the patient is helped to see the impact of their actions on other an their inter individual behavior. Improve Dialectical Behavioral Therapy (DBT),which is the most common type of psychotherapy used in this patient is especially used in patient who have attempted suicide or self esteem and give better control of momentum in patients for 4 weeks and every week for one hour in the psycotherapic clinic in Razi Psychiatric hospital will be performed by final year Psychiatric resident. "Control group:" Olanzapine is an atypic antipsychotic drug that can reduce aggression and to get better mood by impact on serotonin and dopamin. This drug will be used with the dose of 5 to 15 mg per day according to the patient's response for 6 weeks and the drug used by Abidi pharmaceutical company, According that the only approved treatment for borderline personality disorder is psychotherapy, Dialectical Behavioral Therapy (DBT), the most common type of psychotherapy will be used in theses patients for 4 weeks and every week for one hour in the psycotherapic clinic in Razi Psychiatric hospital will be performed by final year Psychiatric resident. Depression. Timepoint: At the begining of study and 12 weeks after study. Method of measurement: Depression based on Hamilton scale. Impulse control. Timepoint: At the begining of study and 12 weeks after study. Method of measurement: impulse control based on Barratt scale. Aggression. Timepoint: At the begining of study and 12 weeks after study. Method of measurement: Aggression based on Bus and Perry scale. University of social welfare and rehabilitation sciences Approved 2020-01-14 Ethics committee of university of social welfare and rehabilitation sciences No 17, South Ebrahimi Ave, East Ferdos Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)