Protocol summary

Summary
The purpose of the present investigation is to assess the efficacy of scopolamine as an adjuvant agent in the treatment of major depression in a six-week double-blind, placebo controlled trial. 40 adult outpatients who meet the DSM- IV-TR criteria for major depression will participate in the trial. Patients who have a baseline Hamilton Rating Scale for Depression score of at least 22 will be allocated into two groups. 20 patients will receive Citalopram 40 mg/day plus Scoploamine 10 mg/day and 20 participants will receive Citalopram 40 mg/day plus placebo. Patients were assessed by a psychiatrist at baseline and after day 4, 7, 14, 28 and 42. Depression severity will be assessed by Hamilton Depression Rating Scale which will be the primary outcome measure

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201181556N31
Registration date: 2012-01-19, 1390/10/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-19, 1390/10/29
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-11-10, 1390/08/19
Expected recruitment end date
2012-04-10, 1391/01/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Scopolamine as adjuvant therapy in the treatment of major depression: a randomised and double blind study
Public title
Scoploamine in the treatment of major depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of Major Depressive Disorder based on DSM-IV criteria; Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 22. Exclusion criteria: Presence of Psychosis, any other diagnosis in Axis I and II; Receiving psychotropic medications; receiving any antidepressants during past one month or ECT during past two months; Presence of hypothyroidism or cardiovascular problems and pregnancy or nursing women
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2011-04-21, 1390/02/01
Ethics committee reference number
10349

Health conditions studied

1

Description of health condition studied
Major Depressive episode
ICD-10 code
F-32
ICD-10 code description
Major Depressive episode

Primary outcomes

1

Description
Severity of depression
Timepoint
Baseline and day 4, 7 , 14, 28, and 42
Method of measurement
Hamiltion Depression Rating Scale 17-Item

Secondary outcomes

empty

Intervention groups

1

Description
Tablet Citalopram 40 mg/day plusTablet Scoplolamine 10 mg/day as intervention group for 6 weeks
Category
Treatment - Drugs

2

Description
Tablet Citalopram 40 mg/day plus Tablet placebo as control group for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. shahin Akhondzadeh
Street address
Roozbeh Hospital -south Kargar street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. shahin Akhondzadeh
Position
PhD of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital - South Kargar street
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
PhD of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital - South Kargar street
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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