Comparison of Vitamin B12 Supplementation to Selective Serotonin Reuptake Inhibitor (SSRI) Versus SSRI Antidepressant Treatment Alone

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Aga Khan University.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Aga Khan University

ClinicalTrials.gov Identifier:

NCT00939718

First received: July 14, 2009

Last updated: May 28, 2010

Last verified: May 2010

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Antidepressants B Vitamins

Drug Information available for: Cyanocobalamin Vitamin B Complex Cobalamin Hydroxocobalamin

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]


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
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided


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
Health Authority:	Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:


depression;vitamin B12;randomized control trial

Additional relevant MeSH terms:


Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Antidepressive Agents Hydroxocobalamin Vitamin B 12 Vitamin B Complex Vitamins	Central Nervous System Agents Growth Substances Hematinics Hematologic Agents Micronutrients Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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