Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.

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Detailed Description

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SAMe is a substance that is naturally produced by the body and is also sold as an over-the-counter drug. Although SAMe has not yet been approved for treating depression, evidence suggests that it has antidepressant properties. This study will determine whether SAMe is safe and effective in treating major depression.

This study will last 24 weeks. Participants will be randomly assigned to receive either the antidepressant escitalopram, SAMe, or placebo for 12 weeks. Participants who respond to treatment at the end of 12 weeks will stay on their regimen for an additional 12 weeks. Participants who do not respond to treatment will enter an open treatment phase where they will receive SAMe and escitalopram for 12 more weeks. Depression scales and self-report questionnaires will be used to assess participants. All participants will receive 3 months of follow-up care, including free medication and clinic visits as necessary.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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S-adenosyl-l-methionine (SAMe)

A natural substance

Group Type EXPERIMENTAL

S-adenosyl-l-methionine

Intervention Type DRUG

1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks

2. Escitalopram

A selective serotonin reuptake inhibitor (SSRI)

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks

3. placebo

Sugar pill- contains no active ingredients

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo capsules look like escitalopram capsules and SAMe capsules

Interventions

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S-adenosyl-l-methionine

1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks

Intervention Type DRUG

Escitalopram

10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks

Intervention Type DRUG

Placebo

placebo capsules look like escitalopram capsules and SAMe capsules

Intervention Type DRUG

Other Intervention Names

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SAMe Lexapro

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of major depression
* Score of 25 or higher on the Inventory of Depressive Symptomatology (IDS-C) scale
* Score of higher than 2 on the Clinical Global Impression Improvement (CGI) scale
* Willing to use acceptable methods of contraception

Exclusion Criteria

* Suicidal or homicidal
* Unstable illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
* Any of the following mental conditions: organic mental disorders; schizophrenia; delusional disorder; psychotic disorders; bipolar disorder; recent bereavement; severe borderline or antisocial personality disorder; panic disorder; or obsessive compulsive disorder
* Substance abuse, including alcohol abuse, within 6 months prior to study entry
* Uncontrolled seizure disorder, or a seizure disorder controlled with psychotropic anticonvulsants
* Psychotic features
* Current use of other psychotropic drugs
* Hypothyroidism
* Have taken 6 weeks or more of either escitalopram or SAMe during the current depressive episode
* Previous intolerance of SAMe or escitalopram
* Investigational psychotropic drugs within 1 year prior to study entry
* Have received two or more antidepressant therapies of adequate doses and duration and failed to respond
* Have received depression-focused psychotherapy
* Bleeding tissue disorder, low platelet counts, a history of GI bleeding, or use of medications that alter bleeding risk
* Long-term aspirin use
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No