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Major DepressionPhase 4NCT00203723

Use of Risperidone in ECT for Treatment Resistant Depression

A Phase 4 study testing Risperidone in people with Major Depression, run by University of California, Los Angeles at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if the combination of risperidone and ECT improves a patient's response in depression compared to ECT alone. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Major Depression
What is being tested?
Risperidone
How many people
45 participants
Where
1 siteUnited States
Study dates
Mar 2005to May 2006
Phase
Phase 4
Are there results?
None posted in the registry

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 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 to 89 years, inclusive
  • Male or female
  • Inpatient or outpatient ECT with a current diagnosis of unipolar or bipolar depression, with or without psychosis, according to DSM-IV criteria. HAM-D (17-item) score > 17 and MADRS score > 18 at screening and at first treatment session.

Who cannot join

  • MMSE < 23
  • Inability to consent to ECT
  • Current diagnosis of schizophrenia or schizoaffective disorder
  • Current diagnosis of Parkinson's Disease or any Dementia, including Lewy Body Disease
  • History of allergic reaction to risperidone
  • History of Neuroleptic Malignant Syndrome
Show all 9Show fewer
  • Current pregnancy or positive urine pregnancy test
  • Women who are breast-feeding
  • Active alcohol or illicit substance abuse

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCLA Npi&H

    Los Angeles, California, 90024

Other trials in United States

About this study

Official title: A Comparison Study of Combined ECT and Risperidone Versus ECT Alone for Treatment Resistant Depression.

The purpose of this study is to determine if the combination of risperidone and ECT improves a patient's response in depression compared to ECT alone.

Read the detailed description

Medication resistance to antidepressant therapy, or Treatment-Resistant Depression (TRD), is the main reason, if not main indication, for which patients are presently referred for electroconvulsive therapy (ECT) in hopes of a rapid, definitive response (APA 2001 ECT Task Force Report). While the causes of TRD remain unclear, this category of patients includes those who have incomplete remission, those who relapse rapidly and frequently, those who have psychotic depression, those who develop chronic depression, and those who often have comorbid medical and psychiatric illness (Sackeim 2001, Sharma 2001, Fava and Davidson 1996, Thase 1995). Moreover, while increased age per se is not a barrier to antidepressant response, many elderly, especially those with comorbid medical or neurological illness, are unable to tolerate courses of aggressive pharmacotherapy or seem to have a less robust response to pharmacotherapy, and possibly to ECT alone, with significant residual functional and cognitive impairment (Reynolds 1998, Stoudemire 1998, Lebowitz 1997, Gurland 1991).

Compared to patients who are not medication resistant, who generally retain the highest likelihood of response to ECT alone, patients with TRD have a lower response rate to ECT with average estimates of response to ECT alone between 50-60% (APA 2001 ECT Task Force). Additionally, while ECT for most patients may provide acute remission, those patients with TRD remain at high risk for rapid relapse (Sackeim 2001, Petrides 2001, Sackeim 1990, Aronson 1987). Consequently, ECT alone may be insufficient to achieve remission or to prevent relapse. Interestingly, resistance to some types of medication was found also to predict resistance to ECT alone, i.e., resistance to tricyclic antidepressants correlated with a less likely response to ECT, though the same prediction did not hold for serotonin reuptake inhibitors (Prudic 1996, Prudic 1990).

In general, for some patients with TRD, studies support the use of combined medication approaches, and specifically, have demonstrated the safety, tolerability and effectiveness of an antidepressant with an antipsychotic medication, though usually for patients with comorbid psychosis (Wheeler 2000, Shelton 1999, Barak 1999). Case reports exist in the ECT literature about the safety and tolerability of ECT and antipsychotics, and improved efficacy, albeit generally for patients with psychotic depression or other treatment resistant psychoses (Kupchik 2000, Bhatia 1998, Ranjan 1996, Farah, Beale, and Kellner 1995, Minter 1979). However, no studies systematically, or prospectively, investigate whether the specific combination of ECT plus an atypical antipsychotic offers a true treatment alternative to improved efficacy of ECT for patients with TRD.

This study reviews the experience and outcome of combining ECT and an atypical antipsychotic medication, risperidone, for TRD in various populations in an academic, university-based setting, and furthermore, explores in a pilot randomized open-label study whether ECT plus risperidone bears closer scrutiny in more rigorous study designs as a novel treatment approach.

Being tested
Risperidone
Keywords
mood disorder, affective disorder, depression, treatment-resistant
Medical subject headings
Depressive Disorder, Major, Mood Disorders, Depression

What participants receive

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

What is being measured

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

  1. Scores on depression scales after 6 ECT treatments

Secondary outcomes (1)
  1. Scores on Clinical Global Impression Scales and Symptom Checklist

Timeline

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

  1. First posted20 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Study completionMay 2006

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
45 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00203723
Sponsor's protocol ID
UCLA IRB #03-10-049-01
Other IDs
RIS-DEP-405
Status last verified
May 2006
First submitted
13 Sep 2005
Last updated
18 May 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Risperidone in people with Major Depression, run by University of California, Los Angeles at 1 site in United States.

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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 May 2006. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was stopped early. Results are not available in the source record.

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?

Scores on depression scales after 6 ECT treatments. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 May 2006.

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