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Comparison of Vitamin B12 Supplementation to Selective Serotonin Reuptake Inhibitor (SSRI) Versus SSRI Antidepressant Treatment Alone
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Aga Khan University.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Aga Khan University
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00939718
First received: July 14, 2009
Last updated: May 28, 2010
Last verified: May 2010
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Purpose
While treating depression, significant numbers respond poorly to anti-depressants; one cause is vitamin B12 deficiency. The investigators are conducting an open label randomized controlled trial to investigate difference in response to SSRI monotherapy alone versus SSRI and intramuscular B12 replacement in people with low-normal B12 levels. 300 participants will be allocated to each arm of intervention at out patient clinics of the department of Psychiatry at Aga Khan University Hospital, Karachi Pakistan. Baseline and 3 month measurement of depression will be on Hamilton Rating Scale for Depression (Urdu version) and response rates compared.
| Condition | Intervention |
|---|---|
| Major Depressive Disorder | Dietary Supplement: Vitamin B12 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Vitamin B12 Supplementation and SSRI to SSRI Monotherapy in Treating Depression With Low Normal B12: A Randomized Open Label trialComparison of Vitamin B12 Supplementation to SSRI Versus SSRI Antidepressant Treatment Alone |
Resource links provided by NLM:
Further study details as provided by Aga Khan University:
Primary Outcome Measures:
- Decline in HAM-D score of 20% or more from baseline indicating improvement in Depression. [ Time Frame: 03 months ]
| Estimated Enrollment: | 268 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vitamin B12 with antidepressants
Subjects in this arm will receive vitamin B12 supplement (injectable)along with their routine antidepressant treatment as prescribed by their primary physicians. subjects will be blind to their arm allocation and will receive injections in a concealed manner with injection vials covered with foil.
|
Dietary Supplement: Vitamin B12
Vitamin B12 injections containing methylcobalamin 1000 mcg given once every six months along with the routine antidepressant treatment.
Other Name: Injection Bevidox intramuscular
|
|
Placebo Comparator: Placebo injections dextrose water
Subjects in this arm will receive placebo injections which will contain only dextrose water. They will also receive 6 injections on a weekly basis and the injection vials will be covered with foil to ensure masking.
|
Dietary Supplement: Vitamin B12
Vitamin B12 injections containing methylcobalamin 1000 mcg given once every six months along with the routine antidepressant treatment.
Other Name: Injection Bevidox intramuscular
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults between ages 18 to 64 years who meet the criteria for a depressive episode as measured by a score of ≥ 16 on first 17 items of HAM-D (Urdu version.
- Patients with low normal B12 levels in serum (>191 but < 300 pg/ml)
- Those who will provide informed consent
Exclusion Criteria:
- Patients with concurrent unstable medical illness
- History of manic episodes or psychotic illness
- Psychotic symptoms within depressive episode
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00939718
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939718
Locations
| Pakistan | |
| Aga Khan University | |
| Karachi, Sindh, Pakistan, 74800 | |
Sponsors and Collaborators
Aga Khan University
Investigators
| Study Chair: | Anwer Siddiqui, PhD | Aga Khan University |
More Information
| Responsible Party: | Ehsan Ullah Syed ; Associate Professor, Aga Khan University |
| ClinicalTrials.gov Identifier: | NCT00939718 History of Changes |
| Other Study ID Numbers: |
081011PSY |
| Study First Received: | July 14, 2009 |
| Last Updated: | May 28, 2010 |
Keywords provided by Aga Khan University:
|
depression;vitamin B12;randomized control trial |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Vitamins Vitamin B 12 Hydroxocobalamin Antidepressive Agents Vitamin B Complex |
Serotonin Uptake Inhibitors Micronutrients Growth Substances Physiological Effects of Drugs Psychotropic Drugs Hematinics Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |
ClinicalTrials.gov processed this record on September 21, 2017