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Completed

NCT Number: NCT01117857

Duloxetine for Menopausal Depression

The primary objective of the study is to determine if an eight-week intervention with duloxetine significantly reduces depressive symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in depression symptoms in menopausal women. The secondary aim of the study is to examine if an eight-week intervention with duloxetine significantly reduces vasomotor symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in vasomotor symptoms in menopausal women.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Menopause Vasomotor Symptoms

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women age 40 years old or older
  • Menopausal symptoms of at least 3 months duration, including irregular periods and/or hot flushes
  • Minimum score of 15 on the Hamilton Rating Scale for Depression (17-item),
  • Patients will meet criteria for a major depressive episode, verified using the Mini International Neuropsychiatric Interview (MINI).
  • Subjects will be able to be treated on an outpatient basis, and
  • Subjects will be able to provide written informed consent

Exclusion criteria

  • Subjects presently taking antidepressant medication,
  • Subjects currently using hormone replacement therapy,
  • Other Axis I disorders, except Generalized Anxiety Disorder or Panic Disorder, according to the Mini International Neuropsychiatric Interview (MINI)
  • "uncontrolled" narrow angle glaucoma
  • known hypersensitivity to duloxetine or any of the inactive ingredients
  • treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
  • Presence of psychotic symptoms,
  • History of mania or hypomania,
  • HAM-D suicide item score > 3,
  • End stage renal disease or severe renal impairment
  • Abnormal uterine bleeding (heavy or prolonged uterine bleeding, menstrual periods occurring more frequently than every 3 weeks, bleeding after sexual intercourse, spotting between periods) that has not been evaluated by a gynecologist.
  • Subjects with serious or unstable medical illness, including alcohol or substance abuse, cardiovascular, hepatic, respiratory, endocrine, neuralgic, or hematologic disease, history of seizure disorder
  • Subjects taking medications that may interact with duloxetine

Treatment and study plan

Duloxetine

Drug

One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study.

Other names: Cymbalta

Primary outcomes

  1. Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression

    Time frame: Baseline to week 9

    The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.

Secondary outcomes

  1. Change in Menopause Symptoms as Measured by the Greene Climacteric Scale

    Time frame: Baseline to week 9

    The Greene Climacteric Scale (GCS) is a 21-item scale used to quantify the severity of perimenopausal somatic symptoms. Each item is scored 0-3 for a total range of 0-63, with a higher score indicating greater symptom severity.

Other outcomes

  1. Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)

    Time frame: Baseline to week 9

    The GAD-7 is a valid and efficient tool for screening anxiety and assessing its severity in clinical practice and research. Subjects rate the items for severity on a 4-point scale from 0 (not at all) to 3 (nearly every day) for a total range of 0-21. A higher score indicates greater anxiety symptom burden.

  2. Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)

    Time frame: Baseline to week 9

    The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).

  3. Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)

    Time frame: Baseline to week 9

    The CGI is a scale to measure the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Severity is ranked 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. A higher score indicates greater symptom severity.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 6, 2010
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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