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NCT00762268 · ClinicalTrials.gov registry record · NA

A Trial of SAMe for Treatment-Resistant Bipolar Depression

A NA study of Depression and Bipolar Disorder, sponsored by Mclean Hospital.

Completed
Registry status
NA
Development phase
23
Enrollment target
1
Study location

NCT00762268: Completed NA study of Depression and Bipolar Disorder, sponsored by Mclean Hospital.

NCT00762268 is a NA study of Depression and Bipolar Disorder that has completed, run by Mclean Hospital. The registered enrollment target is 23 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00762268, a NA study of Depression and Bipolar Disorder, has completed, sponsored by Mclean Hospital.

COMPLETED
Registry status
NA
Development phase
23 participants
Enrollment target
1
Study location

Study Summary

S-adenosyl-L-methionine (SAMe) is a dietary supplement with antidepressant properties. SAMe's mechanism of action remains unclear, but it appears to be distinct from that of conventional antidepressants. The purpose of this study is to examine the effect of these properties on the mood of bipolar subjects with persistent major depression that has been unresponsive to standard pharmacotherapy.

Primary Outcome

Assessment of current depression symptoms using Montgomery-Asberg Depression Scale (MADRS). All 10 questions on the scale have a 0 (absent)-6(most severe) range for describing symptoms, with the total ranging from 0-60. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.

Interventions

  • DRUG Placebo
  • DRUG SAMe

Study Locations (1)

Massachusetts

  • McLean Hospital - Belmont

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2008-09
Est. Completion 2011-09
Phase NA
Mclean Hospital

140 total trials

What the finished NCT00762268 record still lists

NCT00762268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower).

The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00762268 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00762268 about?

NCT00762268 is a clinical study titled "A Trial of SAMe for Treatment-Resistant Bipolar Depression". S-adenosyl-L-methionine (SAMe) is a dietary supplement with antidepressant properties. SAMe's mechanism of action remains unclear, but it appears to be distinct from that of conventional antidepressants. The purpose of this study is to examine the effect of these properties on the mood of bipolar su...

What is the current status of trial NCT00762268?

This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2008-09. Estimated completion is 2011-09.

What conditions does trial NCT00762268 study?

This clinical trial studies the following conditions: Depression, Bipolar Disorder, Bipolar Depression.

What interventions are being tested in trial NCT00762268?

The interventions under investigation include: Placebo (DRUG), SAMe (DRUG).

Who is sponsoring clinical trial NCT00762268?

This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00762268 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00762268's enrollment target sits among peer trials

23 602nd of 679 higher than 76 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00762268, the US trial registry maintained by the National Library of Medicine. NCT00762268 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.