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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201302203930N18 |
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Date of registration:
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2013-04-06 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Lovastatin for treating manic symptoms of bipolar disorder
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Scientific title:
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Lovastatin effect on the symptom of bipolar mood disorder-manic phase |
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Date of first enrolment:
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2011-11-13 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/4097 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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2-3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Ahmad Ghanizadeh
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Address:
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Hafez Hospital
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Shiraz
Iran (Islamic Republic of) |
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Telephone:
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+98 71 1627 3070 |
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Email:
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ghanizad@sina.tums.ac.ir |
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Affiliation:
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Shiraz University of Medical sciences |
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Name:
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Motahhar Omrani Sigaroodi
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Address:
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Hafez Hospital
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Shiraz
Iran (Islamic Republic of) |
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Telephone:
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+98 71 1627 3070 |
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Email:
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motahhar_omrani@yahoo.com |
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Affiliation:
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Shiraz University of Medical sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: Manic episode of bipolar mood disorder; both gender.
Exclusion criteria: sever uncontrolled medical condition such as hypothyroidism; hypersensitivity to lovastatin; and pregnancy.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
65 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bipolar mood disorder manic or mixed phase.
Manic episode
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Manic episode
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Intervention(s)
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Treatment - Drugs
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Intervention 1: Lovastatin 20 to 40 mg/day. Intervention 2: Placebo.
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Lovastatin 20 to 40 mg/day
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Placebo
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Primary Outcome(s)
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Young Mania Rating Scale. Timepoint: baseline, 2 week, and 4 week. Method of measurement: Interveiw.
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Source(s) of Monetary Support
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Vice chancellor for research, Shiraz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Shiraz University of Medical Sceinces
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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