Major Depressive DisorderNCT01022632
Effect of Curcumin as Nutraceutical in Patients of Depression
A study testing Curcumin, Fluoxetine and Curcumin and Fluoxetine in people with Major Depressive Disorder, run by Government Medical College, Bhavnagar at 1 site in India.
Trial summary
The purpose of this study is to find the effect of commonly used nutraceutical curcumin ( extract of Curcuma longa, commonly called 'Haldi' in Hindi) in patients of depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Curcumin, Fluoxetine and Curcumin and Fluoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depression as diagnosed under DSM-IV Axis I Disorders.
- Score greater than 7 but less then 35 on the 17-item Hamilton Depression (HAM-D) Scale at screening.
- The patient has relative(s) to care for him/her
- Informed consent obtained from the patient or relative
Who cannot join
- Scores greater than 2 on the "suicide" item of HAM-D, or history of suicide attempt(s) in the past 12 months.
- Current suicidal or homicidal risk, as determined by the investigator.
- Clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal.
- History of seizure disorder (other than febrile).
- Patient who has had monoamine oxidase inhibitor , any selective serotonin reuptake inhibitor or any other antidepressant in last 15 days
- Any of the following DSM-IV diagnoses current (within past 3 months) schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent)
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- Patient with history of untreated or unstable thyroid disorder
- Failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or MAOI equivalent, or greater than or equal to 100 mg of sertraline, or its SSRI equivalent.
- Have had other investigational drugs within 30 days or other psychotropic medication within 21 days.
- Known allergy or hypersensitivity to the study medications.
- Receiving psychotherapies which are specifically designed to treat depression, eg, interpersonal psychotherapy during the study period.
- Mental retardation or cognitive impairment, or any disorder that might interfere with their ability to give consent or follow study procedures and requirements.
- In case of female patients, Abstinence or effective method of contraception throughout the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Active Controlled, Open Label, Parallel Group Study to Compare the Efficacy of Extract of Curcuma Longa (Turmeric) With Fluoxetine and to Study Its Effect as an Add on Therapy to Fluoxetine in Patients of Depression
The purpose of this study is to find the effect of commonly used nutraceutical curcumin ( extract of Curcuma longa, commonly called 'Haldi' in Hindi) in patients of depression.
- Conditions
- Major Depressive Disorder
- Being tested
- Curcumin, Fluoxetine, Curcumin and Fluoxetine
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
FluoxetineDrug
Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks
Curcumin and FluoxetineDietary supplement
Curcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Active comparator | Fluoxetine : 20 mg Once a day in morning after taking food for 6 weeks Receives: Drug: Fluoxetine |
| Curcumin | Experimental | Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks Receives: Dietary Supplement: Curcumin |
| Curcumin and Fluoxetine | Experimental | Curcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks Receives: Dietary Supplement: Curcumin and Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate according to HAM-D17 scale
Measured: 6 weeks
Mean change in HAM-D17 score
Measured: Six weeks
Secondary outcomes (3)
Clinical global impression assessment
Measured: Six Weeks
Global efficacy at the end of study
Measured: Six weeks
Change in laboratory parameters (routine hematology and urine)
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Bhavnagar
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Family Welfare Department, Government of Gujarat, India, Arjuna Natural Extracts Ltd.
- Investigators
- Dr. Bharat Panchal, MD, Principal investigator, Professor and Head, Department of Psychiatry, Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022632
- Sponsor's protocol ID
- Pharmacol no.01 /2008 Research
- Status last verified
- Jan 2010
- First submitted
- 26 Nov 2009
- Last updated
- 28 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active Controlled, Open Label, Parallel Group Study to Compare the Efficacy of Extract of Curcuma Longa (Turmeric) With Fluoxetine and to Study Its Effect as an Add on Therapy to Fluoxetine in Patients of Depression
- ClinicalTrials.gov ID
- NCT01022632
- Acronym / sponsor ID
- Pharmacol no.01 /2008 Research
- Conditions
- Major Depressive Disorder
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Government Medical College, BhavnagarUniversity, hospital or other
- Collaborators
- Health and Family Welfare Department, Government of Gujarat, India, Arjuna Natural Extracts Ltd.
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find the effect of commonly used nutraceutical curcumin ( extract of Curcuma longa, commonly called 'Haldi' in Hindi) in patients of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Active comparator | Drug: FluoxetineFluoxetine : 20 mg Once a day in morning after taking food for 6 weeks |
| Curcumin | Experimental | Dietary Supplement: CurcuminCurcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks |
| Curcumin and Fluoxetine | Experimental | Dietary Supplement: Curcumin and FluoxetineCurcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Depression as diagnosed under DSM-IV Axis I Disorders.
- Score greater than 7 but less then 35 on the 17-item Hamilton Depression (HAM-D) Scale at screening.
- The patient has relative(s) to care for him/her
- Informed consent obtained from the patient or relative
Key exclusion criteria (13 listed)
- Scores greater than 2 on the "suicide" item of HAM-D, or history of suicide attempt(s) in the past 12 months.
- Current suicidal or homicidal risk, as determined by the investigator.
- Clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal.
- History of seizure disorder (other than febrile).
- Patient who has had monoamine oxidase inhibitor , any selective serotonin reuptake inhibitor or any other antidepressant in last 15 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminCurcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks | Dietary supplement | Curcumin |
| FluoxetineFluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks | Drug | Fluoxetine |
| Curcumin and FluoxetineCurcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks | Dietary supplement | Curcumin and Fluoxetine |
Primary outcome
Response rate according to HAM-D17 scale
Time frame: 6 weeks
Mean change in HAM-D17 score
Time frame: Six weeks
3 secondary outcomes
Clinical global impression assessment
Time frame: Six Weeks
Global efficacy at the end of study
Time frame: Six weeks
Change in laboratory parameters (routine hematology and urine)
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Bharat Panchal, MD principal investigator
Professor and Head, Department of Psychiatry, Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin, Fluoxetine and Curcumin and Fluoxetine in people with Major Depressive Disorder, run by Government Medical College, Bhavnagar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate according to HAM-D17 scale (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2010.