A Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Mania or Mixed Feature Bipolar I Disorder
Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Mania or Mixed phase of Bipolar I Disorder
Design
Randomized, parallel group clinical trial with blinded outcome assessment in 40 patients with bipolar 1 disorder (a randomization software will be used for this purpose).
Settings and conduct
Considering the importance of the rapid elimination of the symptoms of the acute episode of mania, the present study explored the individual comparison of the therapeutic effects of Sodium Valproate combined with Quetiapine or Haloperidol among patients with bipolar I disorder experiencing an episode of mania or mixed feature admitted to Razi Psychiatric Center of Tehran. All patients and individuals who will be contributing to this trial will be blind to the data.
Participants/Inclusion and exclusion criteria
Patients aged 18 years or above
Patients with mania or mixed feature bipolar I disorder according to DSM-5 criteria, diagnosed as per a psychiatric interview
A history of sensitivity to sodium valproate, quetiapine, and haloperidol
A history of systemic diseases
Experiencing pregnancy and breastfeeding
The presence of substance use disorders
A history of brain blood vessels disease and head trauma
HIV positive patients and uncontrolled diabetic patients
Intervention groups
Patients with mania or mixed phase of Bipolar I Disorder, who will be receiving two different treatment protocols.
Main outcome variables
The duration of the signs and symptoms of active phase
The intensity of the signs and symptoms of active phase
Treatment compliance
General information
Reason for update
Acronym
BQS
IRCT registration information
IRCT registration number:IRCT20150221021168N3
Registration date:2021-05-06, 1400/02/16
Registration timing:prospective
Last update:2021-05-06, 1400/02/16
Update count:0
Registration date
2021-05-06, 1400/02/16
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 33401604
Email address
me.samiei@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Mania or Mixed Feature Bipolar I Disorder
Public title
A Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Bipolar I Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of 18 years or above
Patients were diagnosed with Bipolar I disorder experiencing an episode of acute mania or mixed feature according to psychiatric interview
All participants voluntarily provided a written informed consent form
Exclusion criteria:
History of Sensitivity to Sodium Valproate , Quetiapine and Haloperidol
History of Neurological , Cardiovascular , Respiratory, Blood , kidney, Hepatic , Endocrine, Immunological and other Systemic Disease
Pregnancy and Breastfeeding Period
HIV Positive and Uncontrolled Diabetic patients
Substance Use Disorders
History of Brain Blood Vessels Diseases and Head Trauma
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software will be used for the randomization of two parallel groups in this trial . (https://www.randomization.com )
Blinding (investigator's opinion)
Double blinded
Blinding description
All parties of this clinical trial will remain unaware of the treatment allocation and grouping. Patients, investigators, and healthcare providers will be independent individuals and blinded to the treatment received by the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation
Street address
University of Social Welfare and Rehabilitation Sciences , Koodakyar End close , Student Blvd , Zip Code : 1985713870 , Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1985713870
Approval date
2019-10-08, 1398/07/16
Ethics committee reference number
IR.USWR.REC.1398.195
Health conditions studied
1
Description of health condition studied
Bipolar Mood Disorder with Mania or Mixed feature
ICD-10 code
F31.13
ICD-10 code description
Bipolar disorder, current episode manic without psychotic features, severe Bipolar disorder , current episode mixed
Primary outcomes
1
Description
The relevant mania score obtained by the Young Mania Rating Scale
Timepoint
The assessment of treatment response prior the beginning of the study, as well as 3 and 6 weeks after the study onset
Method of measurement
Young Mania Rating Scale
Secondary outcomes
1
Description
The extent of drowsiness
Timepoint
Three and six weeks after the onset of the study
Method of measurement
The Epworth Sleepiness Scale
Intervention groups
1
Description
First Intervention group: Patients with bipolar 1 disorder with the most recent episode of mania or mixed feature Sodium Valproate 15 mg/kg/day and haloperidol 10 mg/day for 42 days or 6 weeks
Category
Treatment - Drugs
2
Description
Second Intervention group: Patients with bipolar 1 disorder with the most recent episode of mania or mixed feature Sodium Valproate 15 mg/kg/day with Quetiapine 500mg/day for 42 days or 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Gita Sadighi
Street address
Razi Psychiatric Hospital , Amin Abad Road , Rey City , Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1866958891
Phone
+98 21 3340 1604
Fax
+98 21 3340 1604
Email
g_sadighi_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Gita Sadighi
Street address
Razi Psychiatric Hospital , Amin Abad Road, Shahre Ray, Tehran
City
Tehran
Province
Tehran
Postal code
1866958891
Phone
+98 21 3340 1604
Email
g_sadighi_md@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Gita Sadighi
Position
Assistant Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Psychiatric Hospital, Amin Abad Road , Share Ray, Tehran
City
Tehran
Province
Tehran
Postal code
1866958891
Phone
+98 21 3340 1604
Email
g_sadighi_md@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Gita Sadighi
Position
Assistant Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Psychiatric Hospital , Amin Abad Road , Share Ray, Tehran
City
Tehran
Province
Tehran
Postal code
1866958891
Phone
+98 21 3340 1604
Email
g_sadighi_md@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences