The aim of the present study is to assess the efficacy of memantine as an adjuvant agent in the treatment of bipolar disorder(mania episode) in a six-week double-blind, placebo controlled trial. 40 patient with mania hospitalized in Qods Hospitals who meet inclusion criteria will participate in the trial. Patients will be randomly allocated into two groups. The first group (20 patients) will receive lithium carbonate(1-1/2meq/lit) + Risperidone2-6 mg/day plus memantine20 mg/day (10 mg bid); the second group( 20 patients) will receive lithium carbonate(1-1/2meq/lit) + Risperidone2-6 mg/day plus placebo.Severity of mania and extrapyramidal side effects will be assessed by Young Mania Rating Scale and Extrapyramidal Symptoms Rating Scale (ESRS) at baseline and after1, 2, 4 and 6 weeks after the trial started.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091514676N1
Registration date:2013-12-01, 1392/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-01, 1392/09/10
Registrant information
Name
Shahab Bahrami
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 0027
Email address
sh.bahrami@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Memantine as an Adjuvant Therapy in Bipolar Disorder
Public title
Efficacy of Memantine in bipolar
Purpose
Treatment
Inclusion/Exclusion criteria
This study is performed on patients between the years2013 to2014 at Qods Hospital in Sanandaj admitted with a diagnosis of bipolar1 disorder in acute mania phase.
Inclusion criteria:history of bipolar disorder (manic acute phase), with or without psychotic symptoms according to DSM-IV-TR clinical interview by a psychiatrist; earn at least 20 points YMRS mania that has revealed; age 18 to 60 years old; obtaining informed consent from a parent or legal guardian of the patient; living in Sanandaj, Irann.
Exclusion criteria: Alcohol and drug dependence or abuse during the 3 months prior to admission (excluding nicotine or caffeine); psychiatric disorders on Axis II (according to DSM-IV-TR), which can interfere with the study; delirium, dementia and cognitive disorders; Schizophrenia, schizoaffective disorder, and psychotic disorders; evidence of heart disease, kidney disease, liver disease (based on medical records) that may cause difficulty in the study; pregnancy and lactation; mental retardation based on clinical assessment, the therapist; history of drug allergy or adverse drug with risperidone and lithium carbonate or Memantine; any history of seizure; Memantine use of the 3 months prior to admission.
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:
40
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
Kurdistan University of Medical Sciences
Street address
Pasdaran BLV , Pardis of University Sanandaj Kurdistan Iran, Islamic Republic Of