NCT00947375
Lamictal TM, Haloperidol Decanoate in Schizophrenia
The trial's own stop reason says it succeeded, but ClinicalTrials.gov shows no posted results — flagged as a possible orphaned finding.
- Phase
- PHASE4
- Enrollment
- 335
- Sponsor class
- OTHER
- Taxonomy code
- goal_met
What the registry says
“All of the mentioned aim and objectives were achieved before the February 2007”
What real verification found
This trial's results were published as a conference abstract: Aliyev N. "P03-360 - The Effect of Lamotrigine Augmentation to Haloperidol Deaconate [Decanoate] in the Treatment of Resistant Schizophrenia: Randomized, Double-Blind, Placebo-Controlled Study." European Psychiatry, Vol 25, Issue S1 (18th European Congress of Psychiatry, Munich, Feb 27-Mar 2, 2010), page 25-E966. DOI: 10.1016/S0924-9338(10)70966-4 (Cambridge Core / ScienceDirect indexed). Match confidence is high on multiple independent details: same sole author/PI (N. Aliyev, of the Central Mental Clinic for Outpatients of Baku City / Azerbaijan State Advanced Training Institute for Doctors), same intervention (haloperidol decanoate IM + lamotrigine 150-200mg/day vs haloperidol decanoate + placebo), same unusual population descriptor ("resistant schizophrenia... verbal resistant hallucinosis"), same outcome measure (PANSS), same duration (12 weeks), and enrollment in the same order of magnitude (abstract reports 350 randomized in two arms of 175; CT.gov lists 335 actual enrolled -- consistent with initial randomization vs. actual-analyzed counts for the same trial). The abstract reports positive efficacy results matching the CT.gov why_stopped text ("aims and objectives achieved"): 75/168 (44%) responders in the lamotrigine arm vs 1/167 (0.6%) in the placebo arm. Caveat: this is a conference abstract, not a full peer-reviewed journal paper -- I found no subsequent full-text article. But per the task's own criteria ("a paper, an abstract, a conference presentation" all count), this satisfies "was this specific trial's result ever published." So although ClinicalTrials.gov shows has_results=false (no structured results posted to the registry), the positive result did NOT sit fully unpublished -- it surfaced at a major European psychiatry congress. I also confirmed via a Cochrane systematic review (CD005962, "Lamotrigine for schizophrenia") and related meta-analyses on lamotrigine augmentation of antipsychotics that this is a real, active research question with several other RCTs (Tiihonen 2003, Kremer 2004, Goff 2007, Zoccali 2007) -- the Aliyev/Baku trial does not appear to be cited within Cochrane's core RCT list (which favors clozapine-augmentation trials in Western journals), suggesting the abstract, while published, is obscure and undercited -- but it is not "unused."
Full search & fetch trail
WebSearch: "NCT00947375 Lamictal Haloperidol Decanoate Schizophrenia"; WebSearch: "Central Mental Clinic for Outpatients" Baku lamotrigine haloperidol schizophrenia trial; WebSearch: "Nadir Aliyev" Baku psychiatry schizophrenia lamotrigine publication; WebSearch: lamotrigine augmentation antipsychotics schizophrenia meta-analysis Cochrane; WebFetch on researchgate.net/publication/331408996 (403 blocked) and cochrane.org/evidence/CD005962 (fetched, inconclusive on study list); WebSearch: Aliyev "lamotrigine" "haloperidol decanoate" schizophrenia PANSS 2009 OR 2010 published (found ScienceDirect/ResearchGate hits for abstract P03-360); WebSearch: "P03-360" lamotrigine haloperidol European Psychiatry 2010 Aliyev; WebSearch: "The effect of lamotrigine augmentation to haloperidol" schizophrenia European Psychiatry abstract; WebFetch on sciencedirect.com abstract page (403 blocked, authenticated); WebFetch on cambridge.org Core article page for P03-360 (succeeded -- returned full citation and abstract text, confirming the match).