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Lifestyle Intervention for Depression

N/A
Waitlist Available
Led By Louisa Sylvia, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial is testing a lifestyle intervention for women with a history of depression who are trying to conceive or are pregnant, in order to prevent excessive weight gain and improve other markers of metabolic health.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of treatment on Client Satisfaction Questionnaire (CSQ-8)
Feasibility of treatment measured by participation rates
Secondary outcome measures
Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)
Exercise duration on the Exercise Questionnaire (EQ)
Weight loss

Side effects data

From 2008 Phase 2 trial • 114 Patients • NCT00151411
35%
Diarrhea
22%
headache/migraine
22%
common cold/respiratory tract infection
16%
nausea and/or vomiting
15%
flu
13%
dysmenorrhea/cramps
11%
stomach/abdominal pain or discomfort
9%
musculoskeletal
5%
vaginal infection
5%
dizziness
5%
hair loss
5%
dental issues
4%
fatigue
4%
flatulence
2%
bladder infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Metformin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lifestyle InterventionExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Intervention
2001
Completed Phase 2
~8880

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,331 Total Patients Enrolled
184 Trials studying Depression
29,532 Patients Enrolled for Depression
Louisa Sylvia, PhDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
554 Total Patients Enrolled
1 Trials studying Depression
518 Patients Enrolled for Depression
Marlene Freeman, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
175 Total Patients Enrolled
1 Trials studying Depression
31 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
Louisa Grandin Sylvia 2017. "Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03053323.
All > Pregnancy
~3 spots leftby Apr 2025
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