Prolonging Remission in Depressed Elderly (PRIDE)

Depression Clinical Trial

— PRIDE  

Official title:

Prolonging Remission in Depressed Elderly (PRIDE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028508
• Other study ID #: GCO 09-0429
• Secondary ID: U01MH055495
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2009
• Last updated: April 7, 2017
• Start date: January 2010
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will determine whether medications alone or medications and electroconvulsive therapy (ECT) work best to prevent depressive relapse and to improve quality of life for older people with severe mood disorders.

Description:

While advances have been made in the acute treatment of geriatric depression, failure to maintain remission following successful treatment remains a major public health problem. In particular, loss of antidepressant response can result in ongoing functional impairment and increased risk of suicide. This is especially salient for severe and/or treatment resistant illness, even after successful ECT.

This trial builds upon the work of the Consortium for Research in Electroconvulsive Therapy (CORE) group that showed that continuation ECT and combination pharmacotherapy were equally effective in preventing relapse following response to acute ECT. We are now testing whether combined pharmacotherapy and ECT, individualized according to patient response, will be more effective in maintaining remission in depressed older adults than pharmacotherapy alone. Moving beyond the traditional fixed schedule for continuation ECT, we are introducing a novel Symptom-Titrated Algorithm-Based Longitudinal ECT (STABLE) regimen. The STABLE algorithm ensures that the timing of ECT treatments is based upon clinical need, helping to achieve the dual goals of adequately treating people showing early signs of symptom re-emergence, while preventing the over-treatment of patients who may be in a stable remission. The continuation therapy "usual care" comparator arm is the combination pharmacotherapy of Li plus VLF (PHARM).

At 7 sites, 322 patients will receive an acute course of right unilateral (RUL) ECT augmented by standardized medication (Phase I); 188 remitters are randomly assigned to one of the 2 groups and followed for 6 months (Phase II). To balance the amount of clinical contact, the schedule of clinic and telephone ratings will be identical for patients in both the PHARM and STABLE arms. For both groups, relapse is defined as Hamilton Rating Scale for Depression-24 (HRSD24) scores >21 at two consecutive time points, suicidality, or psychiatric hospitalization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• DSM-IV diagnosis of major depressive episode, unipolar, based on the Mini-International Neuropsychiatric Interview (M.I.N.I) for DSM-IV

• ECT is clinically indicated

Exclusion Criteria:

• Lifetime history of bipolar affective disorder, schizophrenia, schizoaffective disorder, or mental retardation

• Current diagnosis of delirium, dementia, or substance abuse/dependence in past 6 months as defined by DSM-IV-TR criteria

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• lithium and Venlafaxine
Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l

Procedure:
• ECT
Procedure: ECT RUL ultra brief pulse ECT, 4 treatments in one month and then treatment on an as-needed basis for 5 months Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l

Locations

Country	Name	City	State
United States	Georgia Regents University	Augusta	Georgia
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	The Zucker Hillside Hospital North Shore-LIJ Health System	Glen Oaks	New York
United States	Hoboken University Medical Center (MSSM satellite site)	Hoboken	New Jersey
United States	Columbia University/New York State Psychiatric Institute	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Weill Cornell Medical College	White Plains	New York
United States	Wake Forest University Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. — View Citation

Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at every week
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 2
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 4
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 5
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 6
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 7
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 8
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 9
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 10
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 11
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 12
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 13
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 14
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 15
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 16
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 17
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 18
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 19
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 20
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 21
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 22
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured by a telephone interview at week 23
Primary	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)	Long-term antidepressant efficacy (Hamilton Rating Scale for Depression); Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.; Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23	Measured at clinic visits at week 24
Secondary	Level of functioning (SF-36)	Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at baseline
Secondary	Level of functioning (SF-36)	Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 4
Secondary	Level of functioning (SF-36)	Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 8
Secondary	Level of functioning (SF-36)	Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 12
Secondary	Level of functioning (SF-36)	Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 16
Secondary	Level of functioning (SF-36)	Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 20
Secondary	Level of functioning (SF-36)	Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 24
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at baseline
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 2
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 4
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 8
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 10
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 12
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 14
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 16
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 18
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 20
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 22
Secondary	Tolerability (Mini Mental State Examination [MMSE])	Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 24
Secondary	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at baseline
Secondary	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 4
Secondary	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 8
Secondary	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 12
Secondary	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 16
Secondary	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 20
Secondary	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])	Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at week 24
Secondary	Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency	Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24	Measured at baseline
Secondary	Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency	Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24	Measured at weeks 12
Secondary	Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency	Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24	Measured at weeks 24
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at baseline
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 2
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 4
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 6
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 8
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 10
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 12
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 14
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 16
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 18
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 20
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 22
Secondary	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)	Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Measured at week 24