Major Depressive DisorderPhase 1/2NCT00612807

Treatment of Mood and Marriage Study (TOMMS)

A Phase 1/2 study testing Weekly marital therapy and As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc. in people with Major Depressive Disorder and Partner Relational Disorder (V61.10), run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Major Depressive Disorder, Partner Relational Disorder (V61.10)
What is being tested?: Weekly marital therapy and As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Jul 2006to Jun 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

One partner must receive a clinical diagnosis of major depressive disorder based upon our assessment
Couples must be living together
Either partner must report marital distress or tension
Willing to take antidepressant medication and participate in weekly marital therapy and assessments
The depressed partner cannot be involved in any other psychosocial treatment
Score above 24 on the Mini Mental Status Exam

Who cannot join

Both partners meet diagnostic criteria for major depressive disorder based on our evaluation
Coexisting bipolar or psychotic disorder
Evidence of a primary substance abuse or dependence disorder
Current ECT treatment
Evidence of active and severe domestic violence

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke Child & Family Studies Center; Duke University Medical Center
Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Adapting Marital Therapy in Older Adults With Depression

The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.

Read the detailed description

Major depression has been associated with many individual and interpersonal problems in later life, including inadequate social support, marital distress, spousal depression, poor physical health, and higher rates of mortality. Marital therapy has shown promise as a treatment for depression and coexisting marital distress in younger cohorts, and there is a robust association between social support and depressive symptoms in older adults. The combination of couple therapy and antidepressant medication may provide an ideal treatment for older adults by targeting interpersonal and biochemical aspects of depression.

Couples interested in this study will complete an initial assessment with study personnel. In Phase I, eligible couples will receive weekly marital therapy and the depressed partner will receive medication management with a study doctor for 6 months. In Phase II, couples will be randomly assigned to either the combination treatment (marital therapy plus medication management) or medication management alone for 6 months. At the end of the treatment phase, a thorough assessment will be completed. A follow-up assessment will be completed 6 months after completion of treatment.

Conditions: Major Depressive Disorder, Partner Relational Disorder (V61.10)
Being tested: Weekly marital therapy, As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
Keywords: Older Adults
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Weekly marital therapyBehavioural
Also called Integrative Behavioral Couple Therapy
Weekly marital therapy for 6 months.
As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.Drug
Study doctor may prescribe antidepressant medication for the treatment of depression. Medications will be prescribed according to empirically supported guidelines outlined in the Duke Somatic Treatment Algorithm for Geriatric Depression (STAGED Approach; Steffens, 2002).
SSRIs (daily dose of at least 20 mg for citalopram, 20 mg for fluoxetine, 100 mg for sertraline, 20 mg for paroxetine)
SNRIs (e.g., venlafaxine)
Bupropion SR (achieve dose of at least 150 mg BID)
Mirtazapine
Tricyclic antidepressants (nortriptyline with drug levels 80-120 ng/dl)
Lithium augmentation
MAOI (daily dose of at least 30 mg tranylcypromine or 45 mg of phenelzine)

Study groups in NCT00612807
Study group	Role	What they receive
Control	Active comparator	Medication management with a study doctor every other week. Receives: Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
Combination	Experimental	Medication management with a study doctor every other week plus weekly marital therapy. Receives: Behavioral: Weekly marital therapy; Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.

What is being measured

The primary outcome is the main question the study is designed to answer.

Hamilton Depression Rating Scale (HDRS)
The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression.
Measured: pre-treatment, monthly, post-treatment, 6 month follow-up
Dyadic Adjustment Scale (DAS)
The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning.
Measured: pre-treatment, monthly, post-treatment, 6 month follow-up

Secondary outcomes (5)

Frequency & Acceptability of Partner Behavior
Measured: Pre-treatment, post-treatment, 6 month follow-up
Conflict Tactics Scale
Measured: pre-treatment, post-treatment, 6 month follow-up
SCID Mood Disorders
Measured: pre-treatment, post-treatment, 6 month follow-up
Personal Assessment of Intimacy in Relationships
Measured: pre-treatment, post-treatment, 6 month-followup
Beck Anxiety Inventory
Measured: pre-treatment, post-treatment, 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Jun 2010

First posted12 Feb 2008 (estimated)
Study startJul 2006
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00612807
Sponsor's protocol ID: Pro00008099
Other IDs: R34MH073677-01A2
Status last verified: Mar 2011
First submitted: 2 Jan 2008
Last updated: 24 Jun 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Futterman A, Gallagher D, Thompson LW, Lovett S, Gilewski M. Retrospective assessment of marital adjustment and depression during the first 2 years of spousal bereavement. Psychol Aging. 1990 Jun;5(2):277-83. doi: 10.1037//0882-7974.5.2.277.
PubMed 2378693
Jacobson, N.S. & Christensen, A. (1996). Acceptance and Change in Couple Therapy: A Therapist's Guide to Transforming Relationships. New York: W.W. Norton & Company, Inc.
Oxman TE, Berkman LF, Kasl S, Freeman DH Jr, Barrett J. Social support and depressive symptoms in the elderly. Am J Epidemiol. 1992 Feb 15;135(4):356-68. doi: 10.1093/oxfordjournals.aje.a116297.
PubMed 1550090
Tower RB, Kasl SV. Depressive symptoms across older spouses and the moderating effect of marital closeness. Psychol Aging. 1995 Dec;10(4):625-38. doi: 10.1037//0882-7974.10.4.625.
PubMed 8749590
Gerson S, Belin TR, Kaufman A, Mintz J, Jarvik L. Pharmacological and psychological treatments for depressed older patients: a meta-analysis and overview of recent findings. Harv Rev Psychiatry. 1999 May-Jun;7(1):1-28.
PubMed 10439302
Murrell SA, Himmelfarb S, Wright K. Prevalence of depression and its correlates in older adults. Am J Epidemiol. 1983 Feb;117(2):173-85. doi: 10.1093/oxfordjournals.aje.a113528.
PubMed 6829547
Simons AD, Murphy GE, Levine JL, Wetzel RD. Cognitive therapy and pharmacotherapy for depression. Sustained improvement over one year. Arch Gen Psychiatry. 1986 Jan;43(1):43-8. doi: 10.1001/archpsyc.1986.01800010045006.
PubMed 3942473
Baldessarini RJ. Current status of antidepressants: clinical pharmacology and therapy. J Clin Psychiatry. 1989 Apr;50(4):117-26.
PubMed 2647712
Scogin F, McElreath L. Efficacy of psychosocial treatments for geriatric depression: a quantitative review. J Consult Clin Psychol. 1994 Feb;62(1):69-74. doi: 10.1037//0022-006x.62.1.69.
PubMed 8034832
Thase ME, Greenhouse JB, Frank E, Reynolds CF 3rd, Pilkonis PA, Hurley K, Grochocinski V, Kupfer DJ. Treatment of major depression with psychotherapy or psychotherapy-pharmacotherapy combinations. Arch Gen Psychiatry. 1997 Nov;54(11):1009-15. doi: 10.1001/archpsyc.1997.01830230043006.
PubMed 9366657
Reynolds CF 3rd, Frank E, Perel JM, Imber SD, Cornes C, Miller MD, Mazumdar S, Houck PR, Dew MA, Stack JA, Pollock BG, Kupfer DJ. Nortriptyline and interpersonal psychotherapy as maintenance therapies for recurrent major depression: a randomized controlled trial in patients older than 59 years. JAMA. 1999 Jan 6;281(1):39-45. doi: 10.1001/jama.281.1.39.
PubMed 9892449
Holahan CJ, Moos RH. Social support and psychological distress: a longitudinal analysis. J Abnorm Psychol. 1981 Aug;90(4):365-70. doi: 10.1037//0021-843x.90.4.365. No abstract available.
PubMed 7264067
George LK, Blazer DG, Hughes DC, Fowler N. Social support and the outcome of major depression. Br J Psychiatry. 1989 Apr;154:478-85. doi: 10.1192/bjp.154.4.478.
PubMed 2590779
Levenson RW, Carstensen LL, Gottman JM. The influence of age and gender on affect, physiology, and their interrelations: a study of long-term marriages. J Pers Soc Psychol. 1994 Jul;67(1):56-68. doi: 10.1037//0022-3514.67.1.56.
PubMed 8046584
Jacobson NS, Holtzworth-Munroe A, Schmaling KB. Marital therapy and spouse involvement in the treatment of depression, agoraphobia, and alcoholism. J Consult Clin Psychol. 1989 Feb;57(1):5-10. doi: 10.1037//0022-006x.57.1.5.
PubMed 2647802

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adapting Marital Therapy in Older Adults With Depression
ClinicalTrials.gov ID: NCT00612807
Acronym / sponsor ID: Pro00008099
Conditions: Major Depressive Disorder, Partner Relational Disorder (V61.10)
Keywords: Older Adults
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: Jul 2006
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 12 Feb 2008 (estimated)
Results: Posted 26 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.Medication management with a study doctor every other week.
Combination	Experimental	Behavioral: Weekly marital therapy, Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.Medication management with a study doctor every other week plus weekly marital therapy.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

One partner must receive a clinical diagnosis of major depressive disorder based upon our assessment
Couples must be living together
Either partner must report marital distress or tension
Willing to take antidepressant medication and participate in weekly marital therapy and assessments
The depressed partner cannot be involved in any other psychosocial treatment

Key exclusion criteria (5 listed)

Both partners meet diagnostic criteria for major depressive disorder based on our evaluation
Coexisting bipolar or psychotic disorder
Evidence of a primary substance abuse or dependence disorder
Current ECT treatment
Evidence of active and severe domestic violence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Weekly marital therapyAlso: Integrative Behavioral Couple TherapyWeekly marital therapy for 6 months.	Behavioural	Combination
As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.Study doctor may prescribe antidepressant medication for the treatment of depression. Medications will be prescribed according to empirically supported guidelines outlined in the Duke Somatic Treatment Algorithm for Geriatric Depression (STAGED Approach; Steffens, 2002). SSRIs (daily dose of at least 20 mg for citalopram, 20 mg for fluoxetine, 100 mg for sertraline, 20 mg for paroxetine) SNRIs (e.g., venlafaxine) Bupropion SR (achieve dose of at least 150 mg BID) Mirtazapine Tricyclic antidepressants (nortriptyline with drug levels 80-120 ng/dl) Lithium augmentation MAOI (daily dose of at least 30 mg tranylcypromine or 45 mg of phenelzine)	Drug	Combination, Control

Primary outcome

Hamilton Depression Rating Scale (HDRS)
Time frame: pre-treatment, monthly, post-treatment, 6 month follow-up
The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression.
Dyadic Adjustment Scale (DAS)
Time frame: pre-treatment, monthly, post-treatment, 6 month follow-up
The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning.

5 secondary outcomes

Frequency & Acceptability of Partner Behavior
Time frame: Pre-treatment, post-treatment, 6 month follow-up
Conflict Tactics Scale
Time frame: pre-treatment, post-treatment, 6 month follow-up
SCID Mood Disorders
Time frame: pre-treatment, post-treatment, 6 month follow-up
Personal Assessment of Intimacy in Relationships
Time frame: pre-treatment, post-treatment, 6 month-followup
Beck Anxiety Inventory
Time frame: pre-treatment, post-treatment, 6 month follow-up

Results and safety

Results posted to the registry on 26 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Semi-weekly Medication Management	14	12
Semi-weekly Medication Management + Weekly Marital Therapy	28	28

Primary outcome: Hamilton Depression Rating Scale (HDRS)

Time frame: pre-treatment, monthly, post-treatment, 6 month follow-up. Mean (Standard Deviation). Unit: Score on HDRS

Measure	Semi-weekly Medication Management n = 14	Semi-weekly Medication Management + Weekly Marital Therapy n = 28
Baseline assessment (Depressed spouse)	17.86 (2.11)	19.0 (3.80)
Post-test assessment (Depressed spouse)	5.00 (5.44)	7.29 (5.13)
Follow-up assessment (Depressed spouse)	9.17 (7.52)	8.14 (5.76)
Baseline assessment (Non-depressed spouse)	5.14 (3.76)	8.86 (5.04)
Post-test assessment (Non-depressed spouse)	5.33 (6.56)	3.29 (2.67)
Follow-up assessment (Non-depressed spouse)	3.83 (2.99)	5.71 (4.06)

Semi-weekly Medication Management vs Semi-weekly Medication Management + Weekly Marital Therapy: Interaction term: -0.56, p = 0.056, Fixed effect in multi-level model

Primary outcome: Dyadic Adjustment Scale (DAS)

Time frame: pre-treatment, monthly, post-treatment, 6 month follow-up. Mean (Standard Deviation). Unit: Score on DAS measure

Measure	Semi-weekly Medication Management n = 14	Semi-weekly Medication Management + Weekly Marital Therapy n = 28
Baseline assessment (Depressed spouse)	72.14 (24.30)	84.43 (11.89)
Post-test assessment (Depressed spouse)	84.17 (23.17)	92.27 (16.27)
Follow-up assessment (Depressed spouse)	89.67 (24.23)	91.07 (19.85)
Baseline assessment (Non-depressed spouse)	91.0 (18.32)	88.29 (15.46)
Post-test assessment (Non-depressed spouse)	93.33 (29.75)	97.57 (17.49)
Follow-up assessment (Non-depressed spouse)	104.17 (13.76)	98.31 (20.52)

Semi-weekly Medication Management vs Semi-weekly Medication Management + Weekly Marital Therapy: Interaction term: 0.64, p = 0.32, Fixed effect in multi-level model
Semi-weekly Medication Management vs Semi-weekly Medication Management + Weekly Marital Therapy: Interaction term: -12.97, p = 0.005, Fixed effect in multi-level model

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Semi-weekly Medication Management	0 of 14 (0%)	0 of 14 (0%)	Not reported
Semi-weekly Medication Management + Weekly Marital Therapy	0 of 28 (0%)	2 of 28 (7.1%)	Not reported

Limitations and caveats (from the sponsor): Small sample size limits power to detect differences. Some participants reported difficulty understanding how to complete the questions, which may introduce additional variability into the data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 2378693Futterman A, Gallagher D, Thompson LW, Lovett S, Gilewski M. Retrospective assessment of marital adjustment and depression during the first 2 years of spousal bereavement. Psychol Aging. 1990 Jun;5(2):277-83. doi: 10.1037//0882-7974.5.2.277.
BackgroundJacobson, N.S. & Christensen, A. (1996). Acceptance and Change in Couple Therapy: A Therapist's Guide to Transforming Relationships. New York: W.W. Norton & Company, Inc.
Background: PubMed 1550090Oxman TE, Berkman LF, Kasl S, Freeman DH Jr, Barrett J. Social support and depressive symptoms in the elderly. Am J Epidemiol. 1992 Feb 15;135(4):356-68. doi: 10.1093/oxfordjournals.aje.a116297.
Background: PubMed 8749590Tower RB, Kasl SV. Depressive symptoms across older spouses and the moderating effect of marital closeness. Psychol Aging. 1995 Dec;10(4):625-38. doi: 10.1037//0882-7974.10.4.625.
Background: PubMed 10439302Gerson S, Belin TR, Kaufman A, Mintz J, Jarvik L. Pharmacological and psychological treatments for depressed older patients: a meta-analysis and overview of recent findings. Harv Rev Psychiatry. 1999 May-Jun;7(1):1-28.
Background: PubMed 6829547Murrell SA, Himmelfarb S, Wright K. Prevalence of depression and its correlates in older adults. Am J Epidemiol. 1983 Feb;117(2):173-85. doi: 10.1093/oxfordjournals.aje.a113528.
Background: PubMed 3942473Simons AD, Murphy GE, Levine JL, Wetzel RD. Cognitive therapy and pharmacotherapy for depression. Sustained improvement over one year. Arch Gen Psychiatry. 1986 Jan;43(1):43-8. doi: 10.1001/archpsyc.1986.01800010045006.
Background: PubMed 2647712Baldessarini RJ. Current status of antidepressants: clinical pharmacology and therapy. J Clin Psychiatry. 1989 Apr;50(4):117-26.
Background: PubMed 8034832Scogin F, McElreath L. Efficacy of psychosocial treatments for geriatric depression: a quantitative review. J Consult Clin Psychol. 1994 Feb;62(1):69-74. doi: 10.1037//0022-006x.62.1.69.
Background: PubMed 9366657Thase ME, Greenhouse JB, Frank E, Reynolds CF 3rd, Pilkonis PA, Hurley K, Grochocinski V, Kupfer DJ. Treatment of major depression with psychotherapy or psychotherapy-pharmacotherapy combinations. Arch Gen Psychiatry. 1997 Nov;54(11):1009-15. doi: 10.1001/archpsyc.1997.01830230043006.
Background: PubMed 9892449Reynolds CF 3rd, Frank E, Perel JM, Imber SD, Cornes C, Miller MD, Mazumdar S, Houck PR, Dew MA, Stack JA, Pollock BG, Kupfer DJ. Nortriptyline and interpersonal psychotherapy as maintenance therapies for recurrent major depression: a randomized controlled trial in patients older than 59 years. JAMA. 1999 Jan 6;281(1):39-45. doi: 10.1001/jama.281.1.39.
Background: PubMed 7264067Holahan CJ, Moos RH. Social support and psychological distress: a longitudinal analysis. J Abnorm Psychol. 1981 Aug;90(4):365-70. doi: 10.1037//0021-843x.90.4.365. No abstract available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jill S. Compton, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale (HDRS) (time frame: pre-treatment, monthly, post-treatment, 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00612807, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.