Objectives: Evaluate the Effectiveness of Memantine as Adjuvant Treatment on the Symptoms of Acute Mania in the Patients with Bipolar 1 Disorder. Design: This study is a double-blind with non-randomized sampling method. A total of 90 patients were chosen with bipolar mania that referred to Amir Kabir Hospital. They Sequentially will divide into intervention (n=45) and control (n=45) groups. The intervention group will receive 20 to 30 mg memantine per day, 20 to 30 mg per kg valproate sodium per day and 10 to 25 mg olanzapine per day. Also, the control group will receive placebo, 20 to 30 mg per kg valproate sodium per day and 10 to 25 mg olanzapine per day. Study will perform during the eight weeks and patients will be put under evaluation by Young Mania Rating Scale at the beginning of the study, second week, fourth week and eighth week. Inclusion criteria: Between 18 to 60 years old; Meet the criteria for bipolar disorder based on DSM-1V-TR diagnostic criteria and clinical interview by a psychiatrist; Existence of mania, with a minimum score of 20 in Young Mania Rating Scale; Lack of psychiatric diseases; Without mental retardation; Lack of any disease that make a problem in the clinical study; Do not consume narcotic, stimulants and alcohol except nicotine in the three last months; Do not electroconvulsive therapy in the previous month; Not pregnant; Without drug allergy and drug side effects history on the this study drugs; Do not consume memantine in the three last months; Lack of dementia, delirium, cognitive disorders and epilepsy. Exclusion criteria: Drugs side effect that causing discontinuation of consume them; Request by the patient or the patient's parent or legal guardian to withdraw from the study at any time of the study; Consume of alcohol or narcotic by the patient after starting the study; Lack of response to the drug therapy after 2 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121725031N6
Registration date:2017-01-30, 1395/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-30, 1395/11/11
Registrant information
Name
Fatemeh Rafiei
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 5732
Email address
a.rafiei@tafreshu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of Memantine as Adjuvant Treatment on the Symptoms of Acute Mania in the Patients with Bipolar 1 Disorder
Public title
Evaluating the Effectiveness of Memantine on the Symptoms of Acute Mania in the Patients with Bipolar 1 Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Between 18 to 60 years old; Meet the criteria for bipolar disorder based on DSM-1V-TR diagnostic criteria and clinical interview by a psychiatrist; Existence of mania, with a minimum score of 20 in Young Mania Rating Scale; Lack of psychiatric diseases; Without mental retardation; Lack of any disease that make a problem in the clinical study; Do not consume narcotic, stimulants and alcohol except nicotine in the three last months; Do not electroconvulsive therapy in the previous month; Not pregnant; Without drug allergy and drug side effects history on the this study drugs; Do not consume memantine in the three last months; Lack of dementia, delirium, cognitive disorders and epilepsy. Exclusion criteria: Drugs side effect that causing discontinuation of consume them; Request by the patient or the patient's parent or legal guardian to withdraw from the study at any time of the study; Consume of alcohol or narcotic by the patient after starting the study; Lack of response to the drug therapy after 2 weeks.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not 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 Committe of Arak University of Medical Sciences
Street address
Basij Square, Sardasht, Arak, Iran
City
Arak
Postal code
Approval date
2014-05-05, 1393/02/15
Ethics committee reference number
93-162-14
Health conditions studied
1
Description of health condition studied
Bipolar I disorder
ICD-10 code
F31.0
ICD-10 code description
Bipolar affective disorder, current episode hypomanic
Primary outcomes
1
Description
Clinical symptoms of mania
Timepoint
At the beginning of treatment, second week, forth week and eighth week.
Method of measurement
Young Mania Rating Scale Measure
Secondary outcomes
empty
Intervention groups
1
Description
Placebo capsule, once a day will start at the baseline and after 3 days will increase to twice a day. In the sixth day, placebo dose will increase to 3 times a day and will continue with same dose until eighth week. Also, valproate sodium 20 to 30 mg and olanzapine 10 to 25 mg once a day will start at the baseline and will continue with same dose until eighth week.
Category
Placebo
2
Description
Memantine 10 mg capsule, once a day will start at the baseline and after 3 days will increase to twice a day. In the sixth day, memantine dose will increase to 3 times a day and will continue with the same dose until eighth week. Also, valproate sodium 20 to 30 mg and olanzapine 10 to 25 mg once a day will start at the baseline and will continue with same dose until eighth week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Dr. Alireza Rafiei
Street address
Amir-Kabir Hospital, Parastar Square, Arak, Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical Sciences