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Trial registered on ANZCTR


Registration number
ACTRN12613001275752
Ethics application status
Not yet submitted
Date submitted
14/11/2013
Date registered
19/11/2013
Date last updated
19/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of supplementary oral 5-hydroxytryptophan on severity of depression in patients on chronic selective serotonin reuptake inhibitors; a clinical trial
Scientific title
The effect of supplementary oral 5-hydroxytriptophan plus other essential elements (Dr Daniel capsule) on severity of depression, quality of life and the level of urinary 5-Hydroxyindoleacetic acid in patients with major depression on chronic selective serotonin reuptake inhibitors
Secondary ID [1] 283596 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depression 290518 0
Condition category
Condition code
Mental Health 290905 290905 0 0
Depression
Alternative and Complementary Medicine 290906 290906 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three groups of patients with major depression (80 patients in each group) on chronic (over 6 months) selective serotonin reuptake inhibitors (SSIRs) will randomly receive daily oral 5-hydroxytriptophan (5-HTP) 50 or 300 mg plus other elements including 500 mg (in cases on 50 mg 5-HTP) or 3000 mg (in cases on 300 mg 5-HTP) L-tyrosin, 500 mg cysteine, 1.5 mg pyrodoxine and 0.05 mg selenium (Dr Daniel capsule) in the intervention groups; or oral placebo (glucose) in the control group for 3 consecutive months. Exercise and diet profiles will be similar during the study period in all three groups.
Adherence interventions will include monthly instruction in forms of oral and written material. Adherence to taking medication will be monitored by drug capsule return monthly.
Intervention code [1] 288285 0
Treatment: Drugs
Comparator / control treatment
All the patients will continue their previous treatment including taking SSIRs. Patients in the control group will receive oral placebos (capsules identical to those with medication in the intervention groups, containing only glucose) once daily for 3 consecutive months.
Control group
Placebo

Outcomes
Primary outcome [1] 290894 0
Severity of depression according to the Beck Depression Inventory-II
Timepoint [1] 290894 0
baseline, month 3, month 6.
Primary outcome [2] 290895 0
Quality of life according to the World Health Organization Quality of Life Questionnaire
Timepoint [2] 290895 0
baseline, month 3, month 6.
Primary outcome [3] 290896 0
The level of urinary 5-Hydroxyindoleacetic acid (5-HIAA) using high- pressure liquid chromatography
Timepoint [3] 290896 0
Baseline, month 3.
Secondary outcome [1] 305564 0
Possible side effects/complications of SSIRs such as blurred vision, diarrhea/constipation, dizziness, dry mouth, feeling agitated or shaky, loss of appetite, excessive sweating, sexual problems, and sleep problems by asking from patients.
Timepoint [1] 305564 0
baseline, month 3, month 6.
Secondary outcome [2] 305565 0
Possible side effects/complications of 5-HTP supplement such as problems in appetite, sleep, sexual behavior, temperature and pain sensation by asking from patients.
Timepoint [2] 305565 0
baseline, month 3, month 6.

Eligibility
Key inclusion criteria
Patients with major depression on chronic (over 6 months) selective serotonin reuptake inhibitors
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients on anti-depressive medications other than SSIRs, patients with carcinoids, renal disease, or malabsorption.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers will be used for consecutive attending patients at department of psychology.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The Chi-sqaure or Fisher's Exact test for categorical data; One-way ANOVA with Tukey post hoc analysis or the Kruskal-Wallis test with an appropriate post hoc analysis based on data distribution, and the repeated measures analysis for numerical data.
To detect a difference of depression score at least equal to 5 according to the Beck Depression Inventory, with a standard deviation equal to 11.2 (according to previous reports), at a significant level of 5% (a two-sided t-test) with 80% power 79 patients will be needed in each group, which will be augmented to 80 (total=240).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 5626 0
Iran, Islamic Republic Of
State/province [1] 5626 0
East Azerbaijan

Funding & Sponsors
Funding source category [1] 288278 0
University
Name [1] 288278 0
Tabriz University of Medical Sciences, Drug Applied Research Center
Country [1] 288278 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Daniel F Fouladi
Address
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building, Daneshgah St., Tabriz-Iran. Post Code: 51656-65811.
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286995 0
None
Name [1] 286995 0
Address [1] 286995 0
Country [1] 286995 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290172 0
Tabriz University of Medical Sciences
Ethics committee address [1] 290172 0
Ethics committee country [1] 290172 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 290172 0
14/12/2013
Approval date [1] 290172 0
Ethics approval number [1] 290172 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44342 0
Dr Daniel F Fouladi
Address 44342 0
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building., Daneshgah St., Tabriz-Iran. Post Code:51656-65811
Country 44342 0
Iran, Islamic Republic Of
Phone 44342 0
+989144122542
Fax 44342 0
Email 44342 0
medicorelax@yahoo.com
Contact person for public queries
Name 44343 0
Daniel F Fouladi
Address 44343 0
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building., Daneshgah St., Tabriz-Iran. Post Code:51656-65811
Country 44343 0
Iran, Islamic Republic Of
Phone 44343 0
+989144122542
Fax 44343 0
Email 44343 0
medicorelax@yahoo.com
Contact person for scientific queries
Name 44344 0
Daniel F Fouladi
Address 44344 0
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building., Daneshgah St., Tabriz-Iran. Post Code:51656-65811
Country 44344 0
Iran, Islamic Republic Of
Phone 44344 0
+989144122542
Fax 44344 0
Email 44344 0
medicorelax@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.