Conduct DisorderPhase 3NCT00000385
Long-Term Lithium Treatment for Aggressive Conduct Disorder
A Phase 3 study testing Lithium in people with Conduct Disorder and Aggression, run by Drexel University at 1 site in United States.
Trial summary
This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression). Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Conduct Disorder, Aggression
- What is being tested?
- Lithium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Jun 2005
- Phase
- Phase 3
- 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females
- Ages between 9 and 17 years.
- Conduct disorder according to DSM-IV (As rated on the DICA-IV).
- The aggression criterion at screening
Who cannot join
- Mental Retardation.
- Pervasive Developmental Disorder(s).
- Major Depressive Disorder or Dysthymic Disorder.
- Bipolar Disorder.
- Psychotic Disorder (including Schizophreniform Disorder and Schizophrenia).
- Major medical problem such as cardiac, renal, and thyroid diseases, or seizure disorder.
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- History of psychoactive medication in the previous 2 weeks.
- Current Pregnancy in females.
- History of Substance Dependence in the past month.
- Prior to the proposed study, a history of lithium treatment with serum lithium levels of 0.4 mEq/L or higher for a cumulative period of greater than 10 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University College of Medicine at Friends Hospital
Philadelphia, Pennsylvania, 19124
About this study
Official title: Long-Term Lithium for Aggressive Conduct Disorder
This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).
Read the detailed description
Psychotherapeutic agents are often administered without sufficient testing to children and adolescents, often on a long-term basis, to reduce aggression. Many pressures, including managed care, will increase the utilization of pharmacotherapy in the outpatient setting to treat serious problems. Lithium is the most promising agent for the treatment of aggression in children and adolescents. However, it has not been shown that lithium is an effective treatment for these patients in the outpatient (non-hospital) setting, or on a long-term basis. The purpose of this study is to examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).
The proposed study is a two-phased clinical trial of lithium for the treatment of aggression in conduct disorder. Both phases are double-blind and placebo-controlled with randomization and employ a parallel groups design. Phase 1 contains a short-term 8-week controlled trial, with twice as many subjects randomized to lithium as placebo, increasing the pool of potential lithium responders to continue to Phase 2. In Phase 2, lithium responders from Phase 1 enter a 6-month long-term controlled trial. Every attempt is made to define responders to lithium.
- Conditions
- Conduct Disorder, Aggression
- Being tested
- Lithium, Placebo
- Keywords
- Aggressive conduct disorder, Adolescence, Child, Conduct Disorder, Female, Lithium, Male, Placebos, Conduct Disorder -- *drug therapy, Lithium -- *therapeutic use
- Medical subject headings
- Conduct Disorder, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
Lithium 600 mg to 2700 mg per day
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lithium 600 mg to 2700 mg per day Receives: Drug: Lithium |
| 2 | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overt Aggression Scale-Modified
Measured: Weekly in short term phase, Monthly in long-term phase
Clinical Global Impressions-Improvement Item
Measured: Weekly in short term phase, Monthly in long-term phase
Secondary outcomes (4)
Children's Psychiatric Rating Scale-Selected Items
Measured: Weekly in short term phase, Monthly in long-term phase
IOWA
Measured: Weekly in short term phase, Monthly in long-term phase
DOTES
Measured: Weekly in short term phase, Monthly in long-term phase
TESS
Measured: Weekly in short term phase, Monthly in long-term phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startSep 1997
- Primary completionDec 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Richard P. Malone, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000385
- Sponsor's protocol ID
- R29MH057093
- Other IDs
- R29MH057093, DSIR CT-M
- Status last verified
- Nov 2013
- First submitted
- 2 Nov 1999
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Lithium for Aggressive Conduct Disorder
- ClinicalTrials.gov ID
- NCT00000385
- Acronym / sponsor ID
- R29MH057093
- Conditions
- Conduct Disorder, Aggression
- Keywords
- Aggressive conduct disorder, Adolescence, Child, Conduct Disorder, Female, Lithium, Male, Placebos
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 1997
- Primary completion
- Dec 2003 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).
Detailed description
Psychotherapeutic agents are often administered without sufficient testing to children and adolescents, often on a long-term basis, to reduce aggression. Many pressures, including managed care, will increase the utilization of pharmacotherapy in the outpatient setting to treat serious problems. Lithium is the most promising agent for the treatment of aggression in children and adolescents. However, it has not been shown that lithium is an effective treatment for these patients in the outpatient (non-hospital) setting, or on a long-term basis. The purpose of this study is to examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).
The proposed study is a two-phased clinical trial of lithium for the treatment of aggression in conduct disorder. Both phases are double-blind and placebo-controlled with randomization and employ a parallel groups design. Phase 1 contains a short-term 8-week controlled trial, with twice as many subjects randomized to lithium as placebo, increasing the pool of potential lithium responders to continue to Phase 2. In Phase 2, lithium responders from Phase 1 enter a 6-month long-term controlled trial. Every attempt is made to define responders to lithium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LithiumLithium 600 mg to 2700 mg per day |
| 2 | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females
- Ages between 9 and 17 years.
- Conduct disorder according to DSM-IV (As rated on the DICA-IV).
- The aggression criterion at screening
Key exclusion criteria (10 listed)
- Mental Retardation.
- Pervasive Developmental Disorder(s).
- Major Depressive Disorder or Dysthymic Disorder.
- Bipolar Disorder.
- Psychotic Disorder (including Schizophreniform Disorder and Schizophrenia).
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 |
|---|---|---|
| LithiumLithium 600 mg to 2700 mg per day | Drug | 1 |
| PlaceboMatching placebo | Drug | 2 |
Primary outcome
Overt Aggression Scale-Modified
Time frame: Weekly in short term phase, Monthly in long-term phase
Clinical Global Impressions-Improvement Item
Time frame: Weekly in short term phase, Monthly in long-term phase
4 secondary outcomes
Children's Psychiatric Rating Scale-Selected Items
Time frame: Weekly in short term phase, Monthly in long-term phase
IOWA
Time frame: Weekly in short term phase, Monthly in long-term phase
DOTES
Time frame: Weekly in short term phase, Monthly in long-term phase
TESS
Time frame: Weekly in short term phase, Monthly in long-term phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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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.
Richard P. Malone, MD principal investigator
Drexel University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lithium in people with Conduct Disorder and Aggression, run by Drexel University 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 4 inclusion and 10 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 26 Nov 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overt Aggression Scale-Modified (time frame: Weekly in short term phase, Monthly in long-term phase). 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?
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 26 Nov 2013.