CClinicalTrials.gg
Sign In
CompletedNCT01038323Updated Mar 6, 2017Results posted

Drug and Talk Therapy for Fibromyalgia

A Phase 4 interventional study of CBT and milnacipran and CBT with a placebo in Fibromyalgia, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-06.

Sponsored by Indiana University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers.

We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).

Read the detailed description

Qualified participants will take part in a 21-week clinical research study entitled, "Drug and Talk Therapy for Fibromyalgia". We are doing this study to better understand how talk therapies, such as education and cognitive behavioral therapy (CBT), can improve the therapeutic benefits of drug for fibromyalgia.

Savella ®, (milnacipran) is an FDA approved drug for fibromyalgia. The safety and efficacy of Savella has been established in two US-based clinical studies involving over 2,000 patients with fibromyalgia. Because Savella has already been shown to be effective when used in isolation to treat fibromyalgia, we are conducting the study to determine whether combination treatment (Savella + talk therapy) is more efficacious than just Savella alone or talk therapy alone.

Volunteers will be randomized (like flipping a coin) on two different levels:

  1. Each participate will be randomized into one of two groups for medication:

    One group will receive Savella and the other group will receive a placebo (no medicinal value). Both the medication and the placebo will look identical and subjects will not be told into which group they have been placed until the completion of the study. Each participants has 66% chance of receiving Savella and 34% chance of getting the placebo.

  2. The second level of randomization will be to determine which type of talk therapies you will be assigned to. Subjects will be randomly assigned to receive educational instruction relevant to fibromyalgia, OR cognitive behavioral therapy which includes a workbook. Both talk therapies will be provided over the phone once a week for 8 weeks. Each phone session may last for 30 minutes. Importantly, both talk therapies can provide coping tools and information designed to help manage fibromyalgia symptoms.

Study Overview:

Subjects will be asked to visit the Fibromyalgia Clinical Research Center on five separate occasions: Initial Screening (today's visit), Week 1, Week 2, Week 9, and Week 21.

VISIT 1:

  1. Informed consent and initial screening questionnaire,physical assessment
  2. Issue a 'pain score' wrist monitor with instructions to record current pain level three times a day for one week

VISIT 2:

  1. Submit your pain recording
  2. Complete the self-assessment questionnaires via computer
  3. Vital signs check
  4. Undergo pain sensitivity testing
  5. If qualified, subjects be randomized to receive Savella or placebo AND to receive education or cognitive behavioral therapy

VISIT 3:

  1. We will assess the subject's willingness to continue participation.
  2. Review medication diary and medication side-effect checklist.
  3. Schedule PHONE Therapy sessions: 8 thirty minute calls

VISIT 4:

  1. One week prior to this visit, subjects will receive a 'pain score' monitor in order to enter current pain levels three times a day for one week. Then report for this visit.
  2. Review side effect checklist, medication diary.
  3. Completion of self-assessment questionnaires via computer
  4. Undergo pain sensitivity testing

VISIT 5:

  1. One week prior to this visit, subjects will receive a 'pain score' monitor in order to enter current pain levels three times a day for one week. Then report for this visit.
  2. Review side effect checklist, medication diary.
  3. Completion of self-assessment questionnaires via computer
  4. Undergo pain sensitivity testing
  5. Upon visit completion, participants will receive a reduced dose regimen of the medication along with written and verbal instructions to safely discontinue the study medication.
02

Conditions studied

  • Fibromyalgia

Keywords

  • Fibromyalgia
  • FMS
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.

This study's enrollment of 58 is close to the median of 60 across 1,034 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Must be between the ages of 18 to 65 years of age
  2. Must have been diagnosed with fibromyalgia by a rheumatologist
  3. Must have an overall body pain average score ≥ 4
  4. Must be on stable doses of your current medication for at least past four weeks
  5. Must report all medication including herbal supplements and over-the-counter medications that you are currently taking to a member of the research team.
  6. Must limit any changes in your medication(s)during the 21-week study time period unless medically necessary
  7. Must be willing to maintain a medication diary provided to you during the 21-week study period
  8. Must be willing to abstain (not take) any fibromyalgia related medication (including over-the-counter)for at least 6-hours prior to each of the three testing visits. (Otherwise, you may take these medication immediately after pain sensitivity testing has been completed and as prescribed in-between visits)
  9. Must experience the symptoms of fibromyalgia syndrome (FMS) that decreases (limits) your ability to perform daily activities.

Exclusion criteria

Exclusions Criteria:

  1. You have uncontrolled hypertension(high blood pressure) systolic >160 mm Hg or diastolic blood pressure > 100 mm Hg)
  2. If you have a history of: heart disease, glaucoma, or hepatitis
  3. You have been diagnosed with any type of peripheral neuropathy
  4. You have a body mass index (BMI) of more than 34
  5. You currently or frequently have thoughts of harming yourself or committing suicide.
  6. You are in the process of filing, or plan to file for disability benefits within the study timeline.
  7. You plan to undergo an elective surgery within the study timeline.
  8. You have been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue diseases)
  9. You are currently pregnant, are planning to become pregnant, or are breastfeeding
  10. You have been diagnosed with schizophrenia or manic-depressive.

  11. You are currently taking any of the following medications:

    1. fluoxetine, Brand Names: Prozac, Prozac Weekly, Rapiflux, Sarafem
    2. sertraline, Brand Name: Zoloft
    3. paroxetine, Brand Names: Paxil, Paxil CR, Pexeva
    4. citalopram, Brand Name: Celexa
    5. escitalopram, Brand Names: Lexapro
    6. venlafaxine, Brand Names: Effexor, Effexor XR
    7. mirtazapine, Brand Names: Remeron, Remeron SolTab
    8. duloxetine, Brand Name: Cymbalta NOTE: If you are taking any of the medication(s) listed above and are willing to discontinue its use for the duration of this study, you must first discuss your decision with your primary care physician (or prescribing doctor)regarding the appropriate regimen to wean off your current medication and receive his/her written consent before proceeding with enrollment. We will provide you a "Dear Doctor" letter that explains the study details.
  12. If you are currently taking or have ever taken Savella® (milnacipran)
  13. You are currently participating in other pain research study or have previously been enrolled in any study or class in which cognitive behavioral therapy or educational formats were used to help control pain or stress related to fibromyalgia
  14. You are unwilling or unable to comply with the study guidelines

Note: If you have ever experienced an adverse event while taking any type of antidepressant, please alert the research team, while it may not exclude you from participating in the study, it is important that we are aware of the incident in order to keep you safe.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    CBT and milnacipran

    Subjects randomized to this group will receive a combination of eight telephone sessions of Cognitive Behavior Therapy (CBT) and a 21-week regimen of milnacipran.

    Other: CBT and milnacipran

  • Placebo comparator
    CBT and placebo

    Subjects randomized to this arm will receive a series of eight telephone sessions of Cognitive Behavioral Therapy (CBT) along with a 21-week regimen of a placebo(sugar pill)medication.

    Behavioral: CBT with a placebo

  • Active comparator
    Educational with milnacipran

    Subjects randomized to this group will receive a series of eight educational phone calls regarding fibromyalgia along with a 21-week regimen of milnacipran.

    Drug: Educational with milnacipran

Interventions

  • OtherCBT and milnacipran

    Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week "starter pack". Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.

    Also known as: milnacipran, Savella, Cognitive Behavioral Therapy, CBT, fibromyalgia

  • BehavioralCBT with a placebo

    Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of a placebo. Dosing for the placebo begins with a one week "starter pack". Dosage: 12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.

    Also known as: placebo, sugar pills, Cognitive Behavioral Therapy, CBT, fibromyalgia

  • DrugEducational with milnacipran

    Participants will receive a series of eight telephone sessions of fibromyalgia related education along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week "starter pack". Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.

    Also known as: fibromyalgia, fibromyalgia education, milnacipran, Savella

06

What researchers measure

Primary outcomes

  1. Change in Weekly Average Pain Intensity

    Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)

    Time frame: Baseline and Week 21clinic visits

Secondary outcomes

  1. Change in Evoked Pain Scores

    0 to 20 pain scale, with higher pain score representing greater sensitivity to pressure pain stimuli

    Time frame: Baseline and Week 21 clinic visits

  2. Identification of Group Assignment

    Subjects identifying group assignment correctly

    Time frame: week 21

07

Results

Posted Jul 21, 2016

Participant flow

Participant flow — Overall Study
MilestoneCombinationMilnacipranCognitive Behavioral Therapy
Started201919
Completed171715
Not completed324
Withdrew: Withdrawal by subject324

Outcome measures

PrimaryChange in Weekly Average Pain Intensity

Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)

Time frame:
Baseline and Week 21clinic visits
Reported as:
Mean · units on a scale
Change in Weekly Average Pain Intensity
units on a scaleCombinationMilnacipranCognitive Behavioral Therapy
Change in Weekly Average Pain Intensity-2.1 ± .43-0.97 ± 0.43-1.67 ± 0.45
SecondaryChange in Evoked Pain Scores

0 to 20 pain scale, with higher pain score representing greater sensitivity to pressure pain stimuli

Time frame:
Baseline and Week 21 clinic visits
Reported as:
Mean · units on a scale
Change in Evoked Pain Scores
units on a scaleCombinationMilnacipranCognitive Behavioral Therapy
Change in Evoked Pain Scores-0.76 ± 1.2-0.41 ± 1.20.78 ± 1.2
SecondaryIdentification of Group Assignment

Subjects identifying group assignment correctly

Time frame:
week 21
Reported as:
Number · participants
Identification of Group Assignment
participantsCombinationMilnacipranCognitive Behavioral Therapy
Identification of Group Assignment000

Adverse events

Collected over 21 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Combination—0/20 (0%)9/20 (45%)
Milnacipran—0/19 (0%)8/19 (42.1%)
Cognitive Behavioral Therapy—0/19 (0%)3/19 (15.8%)
Most frequent other events
Most frequent other events
EventCombinationMilnacipranCognitive Behavioral Therapy
nauseaGastrointestinal disorders9/208/193/19

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)CombinationMilnacipranCognitive Behavioral TherapyTotal
<=18 years0000
Between 18 and 65 years20191958
>=65 years0000
Age, Continuous
Age, Continuous(years)CombinationMilnacipranCognitive Behavioral TherapyTotal
Mean44.8 ± 8.847.8 ± 10.647.11 ± 11.946.5 ± 10.3
Sex: Female, Male
Sex: Female, Male(Participants)CombinationMilnacipranCognitive Behavioral TherapyTotal
Female19191654
Male1034
Region of Enrollment
Region of Enrollment(participants)CombinationMilnacipranCognitive Behavioral TherapyTotal
United States20191958
Weekly average pain intensity score
Weekly average pain intensity score(units on a scale)CombinationMilnacipranCognitive Behavioral TherapyTotal
Mean6.2 ± 1.26.3 ± 1.36.3 ± 1.36.3 ± 1.2
08

Study locations

1 site
  • Clinical Research Center for Pain, 250 University Blvd
    Indianapolis, Indiana 46202, United States
09

References and documents

Publications

  • Ang DC, Jensen MP, Steiner JL, Hilligoss J, Gracely RH, Saha C. Combining cognitive-behavioral therapy and milnacipran for fibromyalgia: a feasibility randomized-controlled trial. Clin J Pain. 2013 Sep;29(9):747-54. doi: 10.1097/AJP.0b013e31827a784e. PubMed 23446065 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01038323
Lead sponsor
Indiana University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible party
Sponsor
First posted
Dec 23, 2009
Start date
Dec 2009
Primary completion
Sep 2012
Completion
Sep 2012
Results posted
Jul 21, 2016
Last update
Mar 6, 2017

Study contacts

Dennis C. Ang, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Fibromyalgia→

Other studies from this sponsor

Indiana University

Start the discussion