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

Sponsored by:	Aga Khan University
Information provided by:	Aga Khan University
ClinicalTrials.gov Identifier:	NCT00939718

Purpose

While treating depression, significant numbers respond poorly to anti-depressants; one cause is vitamin B12 deficiency. The investigators are conducting a double blind 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 a community mental health clinic in Saddar area (Karachi). Baseline, 4-week 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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Vitamin B12 Supplementation and SSRI to SSRI Monotherapy in Treating Depression With Low Normal B12: A Randomized Control trialComparison of Vitamin B12 Supplementation to SSRI Versus SSRI Antidepressant Treatment Alone

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Dietary Supplements

Drug Information available for: Serotonin Vitamin B 12 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:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vitamin B12 with antidepressants: Active Comparator 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.
Placebo injections dextrose water: Placebo Comparator 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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939718

Contacts

Contact: EHSAN U SYED, MBBS	92 21 34930051 ext 4691	ehsan.syed@aku.edu
Contact: MOHAMMAD WASAY, MBBS	92 21 34930051 ext 4665	mohammad.wasay@aku.edu

Locations

Pakistan, SINDH
Aga Khan University	Recruiting
KARACHI, SINDH, Pakistan, 74800
Contact: EHSAN U SYED, MBBS 92 21 3493 0051 ext 4691 ehsan.syed@aku.edu
Principal Investigator: EHSAN U SYED, MBBS

Sponsors and Collaborators

Aga Khan University

Investigators

Study Chair:

Anwer Siddiqui, PhD

Aga Khan University

More Information

No publications provided

Responsible Party:	Aga Khan University ( Ehsan Ullah Syed ; Associate Professor )
Study ID Numbers:	081011PSY
Study First Received:	July 14, 2009
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00939718 History of Changes
Health Authority:	Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:

depression;vitamin B12;randomized control trial

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Vitamin B Complex
Cyanocobalamin
Hematinics
Hydroxocobalamin
Psychotropic Drugs
Vitamin B 12
Cobalamin
Trace Elements
Depressive Disorder, Major

Depressive Disorder
Serotonin Uptake Inhibitors
Serotonin
Behavioral Symptoms
Methylcobalamin
Vitamin B12
Mental Disorders
Vitamins
Mood Disorders
Micronutrients
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Psychotropic Drugs
Depressive Disorder, Major
Mental Disorders
Vitamins
Therapeutic Uses
Micronutrients
Antidepressive Agents
Vitamin B Complex

Depression
Hematinics
Growth Substances
Hydroxocobalamin
Vitamin B 12
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009